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Reported trial results for Chronic Kidney Disease

Every Chronic Kidney Disease trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

152 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT05834738 · results posted 20 July 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05834738) enrolled 54 people in total — 27 in each group. It tested a medicine called atrasentan against a placebo (a dummy treatment with no active ingredient) in a "crossover" design, meaning participants took one treatment for a period, had a break, then switched to the other. The main thing being measured was the change in protein levels in the urine — specifically a measure called UPCR (the ratio of protein to creatinine in urine collected over 24 hours). High protein in the urine can be a sign of kidney problems, so tracking how this number changes over time was the focus of the study. Almost all participants completed both treatment periods, with only one person not finishing. The reported data shows that, after 12 weeks, the atrasentan group had an average reduction in urinary protein of about 30.7%, while the placebo group had an average reduction of about 7.2%. For a secondary measurement taken at 24 weeks (in the second treatment period), the atrasentan group showed an average reduction of around 27.0%, compared with about 0.9% in the placebo group. These numbers describe what was observed and recorded — they do not on their own tell us whether the differences are meaningful for any individual person. The reported data also shows that the number of participants who experienced treatment-emergent adverse events (that is, unwanted health events that occurred during or after taking the treatment) was 19 out of 27 during the atrasentan first period and 17 out of 27 during the placebo first period, with similar numbers in the second period. Blood levels of atrasentan were also measured and reported in the range of roughly 1.06 to 1.41 nanograms per millilitre across the different time points and groups. The data as submitted does not provide further breakdown of what those adverse events were or how serious they were beyond what is noted above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05254002 · results posted 13 July 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05254002) enrolled 818 people across three groups: one group took both finerenone and empagliflozin together (the combination), one group took finerenone plus a dummy pill (placebo) in place of empagliflozin, and one group took empagliflozin plus a dummy pill in place of finerenone. The trial was primarily measuring a value called UACR — a urine test that shows how much of a protein called albumin is leaking into the urine, which doctors use as a marker of kidney stress in people with type 2 diabetes and chronic kidney disease. Around 240 people in each group completed the full study period. The reported data shows that the main measure — the UACR reading at day 180 compared to the start — was lower in all three groups. In the combination group, the reported ratio was 0.483 (meaning roughly half the starting level), compared to 0.708 in the empagliflozin-only group and 0.683 in the finerenone-only group. A ratio below 1 means the UACR reading went down from the starting point. For the secondary outcomes, the reported data shows that 30 days after treatment stopped (day 210), UACR readings rose back up across all groups compared to the day 180 level — the ratios reported were 1.631 for the combination group, 1.448 for the finerenone-only group, and 1.442 for the empagliflozin-only group. Regarding kidney filtering ability (eGFR — a measure of how well the kidneys clean the blood), at day 30 the combination group showed a reported decrease of about 5.6 units, the finerenone-only group showed a decrease of about 2.0 units, and the empagliflozin-only group showed a decrease of about 3.8 units from their starting values. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05213624 · results posted 12 January 2026

According to the results reported on ClinicalTrials.gov, this trial looked at three different doses of an investigational medicine called BI 764198 (20 mg, 40 mg, and 80 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with a kidney condition. A total of 67 people were enrolled across the four groups. The main thing the trial was measuring was a protein-to-creatinine ratio in urine — essentially, how much protein was leaking into the urine over 24 hours, which is a marker used to monitor certain kidney conditions. Specifically, the trial tracked whether participants' urine protein levels dropped by at least 25% after 12 weeks of treatment. The reported data shows that, using a statistical modelling approach, the predicted percentage of participants whose urine protein levels fell by at least 25% at Week 12 was 48.9% in the 20 mg group, 16.0% in the 40 mg group, 38.5% in the 80 mg group, and 11.4% in the placebo group. For the overall average change in urine protein levels from the start of the trial to Week 12, the reported figures were a reduction of about 38% in the 20 mg group, a reduction of about 2% in the 40 mg group, a reduction of about 22% in the 80 mg group, and a small increase of about 2% in the placebo group. The reported data also shows that blood levels of BI 764198 generally increased with higher doses, as measured at Weeks 4 and 12. The secondary measurements — which looked at changes in urine protein at additional time points — also showed varied results across the different dose groups, with the reported numbers suggesting differing patterns of change depending on the dose and the time point measured. It is worth noting that not all participants who started the trial completed it, particularly in the 40 mg group where six out of 16 did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03608033 · results posted 9 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03608033) enrolled 181 people in the OMS721 group and 179 people in the placebo group during the treatment period. The trial was measuring changes in the amount of protein leaking into the urine over 24 hours (known as proteinuria — a marker that doctors monitor in certain kidney conditions), as well as changes in how well the kidneys were filtering blood over time. The main focus was on participants who had higher levels of protein in their urine at the start of the study (2 grams or more per day). The reported data shows that, at 36 weeks, participants in the high-proteinuria group who received OMS721 had a 21.3% reduction in urinary protein compared to their starting level, while those in the placebo group had a 16.6% reduction. For all participants combined (those with more than 1 gram of protein per day at the start), the reported reductions were 14.2% for the OMS721 group and 10.3% for the placebo group. Regarding kidney filtration rate — a measure of how well the kidneys are working — the reported data shows a decline of 8.3 units per year in the high-proteinuria OMS721 group versus 7.9 units per year in the placebo group, and across all participants, a decline of 6.4 units per year for OMS721 versus 7.6 units per year for placebo. Later time-point measurements (between 36 and 48 weeks, and 36 and 72 weeks) showed small increases in urinary protein in both groups, with the reported figures being similar between OMS721 and placebo. It is also worth noting that a relatively large number of participants did not complete the treatment period — 144 out of 181 in the OMS721 group and 140 out of 179 in the placebo group — though the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05027074 · results posted 17 November 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05027074) enrolled 506 people across three groups: 171 received a higher dose of the investigational drug MK-2060 (20 mg), 167 received a lower dose (6 mg), and 168 received a placebo (an inactive treatment used for comparison). Participants all had an arteriovenous graft — a surgically created connection used for kidney dialysis — and the trial was primarily measuring how often these grafts became blocked by a blood clot (a condition called thrombosis) over time. The reported data shows that for the primary outcome — the rate of a first graft-blocking clot event — the figures were 23.80 events per 100 person-years in the higher-dose MK-2060 group, 22.98 in the lower-dose group, and 30.17 in the placebo group. (A "per 100 person-years" rate is a way of counting how often an event happened across the whole group over time.) When looking at both first and repeat clot events combined (a secondary outcome), the reported rates were 38.95, 37.85, and 42.97 events per 100 person-years respectively. The reported data also shows that bleeding events (a secondary safety-related outcome) occurred at rates of 24.73, 18.05, and 14.04 events per 100 person-years in the higher-dose, lower-dose, and placebo groups respectively. Regarding adverse events (any unwanted medical occurrence during the study), 161, 143, and 155 participants across the three groups experienced at least one. The number of participants who stopped taking the study treatment due to an adverse event was 47, 32, and 46 in the higher-dose, lower-dose, and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05571605 · results posted 20 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05571605) involved 11 people in total — 5 in an Exercise Training group and 6 in a Stretching group. All 11 participants completed the trial with no drop-outs. The trial was measuring how blood pressure changes in the body relate to blood flow changes in the brain — specifically in a large brain artery called the middle cerebral artery. Two things were measured: a "phase" value (which reflects the timing difference between blood pressure and brain blood flow changes) and a "gain" value (which reflects how much brain blood flow changes in response to blood pressure changes). These measurements were taken at two time points — likely before and after each program — though the exact timing labels were not included in the reported data. The reported data shows the following numbers for the phase measurement (in radians, a unit describing timing): the Exercise Training group recorded 1.38 at the first time point and 1.40 at the second; the Stretching group recorded 1.12 at the first time point and 1.60 at the second. For the gain measurement (in cm/s/mmHg, a unit describing how much brain blood flow responds to a blood pressure change): the Exercise Training group recorded 0.65 at the first time point and 0.77 at the second; the Stretching group recorded 0.67 at the first time point and 0.63 at the second. No further statistical comparisons or explanations of these numbers were included in the data submitted to ClinicalTrials.gov. It is worth noting that this was a very small trial with only 11 participants, which limits how much can be drawn from these figures alone. No information about side effects or safety outcomes was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05284656 · results posted 11 June 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05284656) enrolled 80 people in total, split evenly into four groups of 20: one group received folic acid, one received pentoxifylline, one received both folic acid and pentoxifylline together, and one was a control group. All 80 participants completed the study with no drop-outs. The trial was looking at changes in certain blood measurements — specifically a substance called creatinine (a marker used to assess kidney function) and ferritin (a marker related to iron storage in the body) — over a period of six months. The reported data shows that the primary measurement — the change in blood creatinine levels from the start of the trial to six months later — was recorded as follows: the folic acid group had a change of 3.118 mg/dl, the pentoxifylline group had a change of 3.335 mg/dl, the combined folic acid and pentoxifylline group had a change of 3.535 mg/dl, and the control group had a change of 2.872 mg/dl. For the secondary measurement, serum ferritin levels were reported as 200.6 ng/ml for the folic acid group, 334.1 ng/ml for the pentoxifylline group, 245.1 ng/ml for the combined group, and 235.3 ng/ml for the control group. A third measurement — the protein-to-creatinine ratio (used to assess protein in the urine) — was listed as a planned outcome, but no results data was reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04616612 · results posted 23 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04616612) enrolled 22 people in total — 10 in the "SystemCHANGE™" group and 12 in the "Attention Control" group (a comparison group that received a different level of engagement). The trial was measuring how well people took their medications as prescribed, and also gathered information about how acceptable and credible participants found the program. By the end of the study, 4 of the 10 people in the SystemCHANGE™ group and 9 of the 12 in the Attention Control group completed the trial. The reported data shows that the main thing being measured was the percentage of daily medication doses taken as prescribed, tracked using electronic bottle caps that recorded each time they were opened. Two sets of figures were reported for this measure (likely reflecting different time points, though the data does not label them): in the first set, the SystemCHANGE™ group recorded 98% and the Attention Control group recorded 74%; in the second set, the figures were 91% for SystemCHANGE™ and 59% for Attention Control. For the secondary measures, 6 participants from the SystemCHANGE™ group and 8 from the Attention Control group were included in a qualitative (in-depth interview-based) analysis about their experience with the program. On a questionnaire asking how much participants expected the program to benefit them (scored 0–30, where higher means greater expectation of benefit), the reported scores were 29 for SystemCHANGE™ and 23.7 for Attention Control in one reporting period, and 26.83 versus 24.57 in another. On a questionnaire asking how logical and believable participants found the program (also scored 0–30), the SystemCHANGE™ group scored 28.67 and the Attention Control group scored 25.56. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04994522 · results posted 6 April 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04994522) involved 14 participants in total — 8 people with end-stage renal disease (ESRD, meaning their kidneys had stopped working and they required dialysis) and 6 healthy participants. The trial was measuring how the body absorbs, processes, and clears a drug called belzutifan under different conditions: in people with ESRD both before and after a dialysis session, and in healthy individuals. All participants who started each phase of the trial completed it. The reported data shows the following for the key measurements. For the total amount of belzutifan in the bloodstream over time (from dose until it was fully cleared), the figures were 17,100 ng·hr/mL for ESRD participants before dialysis, 21,100 ng·hr/mL for ESRD participants after dialysis, and 18,500 ng·hr/mL for healthy participants. Looking at just the first 24 hours, the figures were 10,700, 12,300, and 13,200 ng·hr/mL respectively. The peak level of belzutifan recorded in the blood was 1,110 ng/mL (ESRD before dialysis), 907 ng/mL (ESRD after dialysis), and 1,300 ng/mL (healthy participants). The time it took to reach that peak level was 2 hours, 4 hours, and 1 hour respectively. The reported data also shows how long it took for the drug level in the blood to fall by half: approximately 15.1 hours (ESRD before dialysis), 17.1 hours (ESRD after dialysis), and 13.9 hours (healthy participants). As a secondary measure, the rate at which dialysis removed belzutifan from the blood was reported as 78.4 mL/min in the ESRD group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03602261 · results posted 30 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03602261) enrolled 44 people in total — 33 took a weekly capsule called CTAP101 at a dose of 900 micrograms, and 11 took a placebo (a dummy capsule with no active ingredient). Of those who started, 25 in the CTAP101 group and 8 in the placebo group completed the study. The trial was measuring two main things in the blood: levels of a form of vitamin D called 25-hydroxyvitamin D (25D), and levels of a hormone called iPTH (intact parathyroid hormone), which is linked to how the body manages calcium and vitamin D. It also tracked how the active ingredient moved through the body over time (known as pharmacokinetics). The reported data shows that when looking at participants who met both targets at once — a vitamin D blood level at or above 50 ng/mL and a reduction in iPTH of more than 30% from their starting level — 4 out of 33 participants in the CTAP101 group reached both goals, compared with 0 out of 11 in the placebo group. Looking at the vitamin D target alone, 28 out of 33 in the CTAP101 group reached a blood level at or above 50 ng/mL, compared with 1 out of 11 in the placebo group. For the iPTH reduction target alone, 4 out of 33 in the CTAP101 group achieved a drop of more than 30%, compared with 0 out of 11 in the placebo group. The reported data also shows some measurements of how the active ingredient behaved in the bloodstream. After a single starting dose, the highest recorded blood level of calcifediol (the active ingredient) was 45.5 ng/mL, reached within about 0.6 hours. After repeated dosing at the end of the study, the peak level rose to 181.0 ng/mL, reached at around 2.5 hours. The total amount of the ingredient measured in the blood over time (a figure called AUC, which captures the overall exposure) was 9,118.4 hour×ng/mL after the single dose and 95,820.7 hour×ng/mL after repeated dosing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03819153 · results posted 20 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03819153) enrolled 3,533 participants in total — 1,767 received semaglutide and 1,766 received a placebo (an inactive look-alike treatment). The trial was measuring kidney-related outcomes in people over a period of roughly four and a half years. The main thing researchers were tracking was how many participants experienced a serious worsening of kidney function — defined as a combination of events including a large, lasting drop in how well the kidneys filter blood (known as eGFR, a measure of kidney filtering ability), kidney function falling to a very low level, needing to start dialysis or have a kidney transplant, dying from a kidney-related cause, or dying from a heart or blood vessel-related cause. The reported data shows that, for this combined ("composite") main outcome, 331 participants in the semaglutide group experienced one of these events, compared with 410 participants in the placebo group. Looking at the individual components: a large, lasting drop in kidney filtering ability occurred in 165 semaglutide participants versus 213 placebo participants; kidney filtering ability falling to a critically low level occurred in 92 versus 110 participants respectively; starting dialysis or receiving a kidney transplant occurred in 87 versus 100 participants; and kidney-related death occurred in 5 participants in each group. The reported data also shows that kidney filtering ability declined at an average rate of about 2.19 units per year in the semaglutide group and about 3.36 units per year in the placebo group over the course of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT03631290 · results posted 3 February 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a "deprescribing" programme — that is, a structured approach to reducing or stopping certain medicines that may be less suitable for older adults. A total of 41 patients aged 55 and over were approached about taking part, along with 7 healthcare providers (clinicians). The study identified 85 people from medical records who were potentially eligible, and of the 41 patients who were approached, 17 agreed to go ahead with deprescribing. The reported data shows that 15 deprescribing events occurred through one approach (where the provider communicated directly with the patient), and 2 occurred through a second approach (where only the provider was involved), giving 17 deprescribing events in total. On the provider side, out of 7 clinicians surveyed, 5 reported agreeing or strongly agreeing that the programme "meets my approval," 5 agreed or strongly agreed it "seems doable," and 2 agreed or strongly agreed it "fits their clinical routine." For the secondary outcome, the reported data shows that 7 events were recorded where a patient experienced symptoms that may have been related to cutting back or stopping a medication — these were identified through medical records or reported directly to the study team. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04515849 · results posted 17 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04515849) enrolled 248 participants across five groups: three groups received different doses of an investigational medicine called cotadutide (100 micrograms, 300 micrograms, or 600 micrograms), one group received a placebo (an inactive treatment), and one group received an already-approved medicine called semaglutide. The trial was primarily measuring changes in something called UACR — a urine test that looks at the ratio of two proteins, which is commonly used to assess kidney health in people with diabetes — after 14 weeks of treatment. Body weight and HbA1c (a measure of average blood sugar levels over roughly three months) were also tracked as secondary measures. The reported data shows that after 14 weeks, UACR changed by approximately −11% in the 100 microgram cotadutide group, −40% in the 300 microgram group, and −45% in the 600 microgram group, compared with an increase of about +5% in the placebo group. At 26 weeks, the reported figures were approximately −18%, −39%, and −58% for the three cotadutide doses respectively, compared with an increase of about +12% in the placebo group. For body weight, the reported data shows percentage changes at 26 weeks of roughly −2.6%, −5.5%, and −7.4% for the three cotadutide doses, compared with −2.2% for placebo. For HbA1c at 26 weeks, the reported changes were approximately −0.92%, −0.92%, and −0.89% across the three cotadutide doses, compared with −0.25% for placebo. Results for the semaglutide group versus cotadutide were described as exploratory and were not included in the primary or secondary outcome reporting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04626427 · results posted 16 January 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 14 people who were fitted with the WavelinQ™ EndoAVF System — a device used to create an arteriovenous fistula (AVF), which is a surgically created connection between an artery and a vein that can be used for kidney dialysis. The trial was measuring safety (specifically, whether participants experienced serious unwanted events linked to the device or procedure) and effectiveness (how often additional procedures were needed to maintain or support use of the AVF). It is important to note that the trial was ended early, meaning no participants fully completed the planned follow-up schedule, and the results are therefore based on limited data. The reported data shows that, out of the 13 participants assessed for the main safety measure, 12 were reported as being free from serious adverse events (serious unexpected health problems) that were judged by an independent review committee to be related to the device or procedure, while 1 participant experienced such an event. For the effectiveness measure, the reported data shows an average of 1.00 additional procedures per patient-year were needed to help maintain or support use of the AVF. A secondary measure looked at whether the AVF reached a level of physical development considered suitable for dialysis use; the reported data shows 12 out of 13 participants assessed met that definition, with 1 not meeting it. Regarding successful first use of the AVF for dialysis (using two needles), the reported data shows approximately 46% of participants achieved this within a 6-month window based on a statistical estimation method, and around 73% of those who reached the 6-month follow-up point were estimated to have achieved it. The exact number of days it took participants to reach successful first use was not reported in a summary figure due to insufficient data points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04571619 · results posted 13 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04571619) compared two groups of people with pain: one group received a programme called Pain Coping Skills Training (PCST) — a structured approach to learning mental and behavioural strategies for managing pain — and the other group received their usual care. A total of 643 people started the trial (319 in the PCST group and 324 in the usual care group), and the study tracked them across two phases. The main thing being measured was how much pain interfered with participants' daily lives, using a standard questionnaire called the Brief Pain Inventory (BPI) Interference Scale, scored from 0 (no interference) to 10 (worst interference). The reported data shows that at the start of the trial, both groups had similar pain interference scores — 6.26 for the PCST group and 6.45 for the usual care group. By the end of Phase 2, those scores had changed to 5.09 for the PCST group and 5.75 for the usual care group (lower numbers mean less interference). The reported data also shows scores across several secondary measures taken at multiple time points. Pain intensity scores (scale 0–40) moved from around 5.83 and 5.98 at the start, down to 4.74 and 5.10 by the final time point, for the PCST and usual care groups respectively. Pain catastrophising scores (scale 0–24, where higher is worse) started at 15.5 in both groups and reached 12.8 and 13.7 by the final time point. For opioid use (measured in morphine milligram equivalents per day), the PCST group started at 45 and the usual care group at 24, with both groups' figures remaining in a similar range across time points. Falls were also tracked: the PCST group had 138 total falls at a rate of 0.66 falls per patient-year, while the usual care group had 155 falls at a rate of 0.70 falls per patient-year. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT02532621 · results posted 1 January 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 158 people who all received a device called the Venous InterGraft Connector (VIG) — a connector used when placing an arteriovenous (AV) graft, which is a surgically created loop under the skin that allows patients to be connected to a dialysis machine. The trial was measuring how well the graft stayed open and usable for dialysis over time, how quickly it could first be used, and what events occurred along the way. Of the 158 people who started, 132 completed the study, with 26 not completing it (the reasons were not broken down in the reported data). The reported data shows that for the main (primary) outcome — whether the graft remained usable for dialysis at 6 months — 146 out of 158 participants were recorded as meeting that measure. For the secondary outcomes, all 158 participants were recorded as having blood flowing through the graft at the end of the implant procedure. The reported data shows that 95 participants were free from both a blockage in the graft and any procedure needed to keep it open (called "primary unassisted patency"). The average time from placing the graft to first using it for dialysis was reported as 20.1 days. Regarding interventions needed to keep the graft working, the reported numbers show 33, 14, 8, and 103 participants across different categories, though the breakdown labels for each category were not included in the submitted data. For serious adverse events — defined in this trial as death, emergency surgery, significant bleeding, graft infection, or pseudoaneurysm (a type of abnormal blood-filled bulge) — the reported data shows 3 participants recorded under one category, 6 under another, and zero each for three further categories, with 149 participants recorded in the remaining group; again, the specific label for each figure was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04736628 · results posted 4 September 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 261 adults across four groups: three groups received different doses of a medicine called avenciguat (1 mg, 2 mg, or 3 mg, each taken three times a day), and one group received a placebo (a dummy treatment with no active ingredient). The trial ran for 20 weeks and was mainly measuring changes in a kidney marker called the urine albumin-to-creatinine ratio, or UACR — a measure of how much of a protein called albumin is leaking into the urine, which can indicate how the kidneys are functioning. Most participants completed the study: 58, 60, 60, and 55 people finished in the 1 mg, 2 mg, 3 mg, and placebo groups respectively. The reported data shows that the primary outcome — change in UACR measured from a 10-hour urine collection after 20 weeks — went down (on a log scale) in all three avenciguat groups, with figures of −0.210 for the 1 mg group, −0.190 for the 2 mg group, and −0.217 for the 3 mg group. In the placebo group, the figure was +0.018, meaning it slightly increased. For a secondary measure using first-morning urine samples, the reported changes were −0.190, −0.180, and −0.161 for the three avenciguat doses respectively, compared with +0.027 for placebo. The reported data also shows that the number of participants whose UACR dropped by at least 20% from their starting level (in the 10-hour urine sample) was 25, 27, and 31 in the avenciguat groups versus 14 in the placebo group; similar patterns were seen in the first-morning urine results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00645658 · results posted 26 August 2024

According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants: nine people with chronic kidney disease and eight people without kidney disease (the control group). The study was measuring body composition and physical health in the chronic kidney disease group, specifically looking at muscle size in the thigh, lean body mass (the weight of everything in the body except fat), total body fat, leg strength, quality of life, and a blood marker of inflammation called C-Reactive Protein (CRP). Eight of the nine kidney disease participants and six of the eight control participants completed the study. The reported data shows the following figures for the chronic kidney disease group at the end of the study: the thigh cross-sectional area (a measure of thigh muscle size captured by a body scan) was reported as 58.2 square centimetres, and lean body mass was reported as 48.2 kilograms. Total body fat was reported as 21.2 kilograms. For quality of life, participants completed a standard 36-question health survey scored from zero to 100, where a higher number reflects better health functioning — the reported average score for the kidney disease group on the symptoms section was 42.1 out of 100. The reported data for leg strength (quadriceps extension) and the inflammation marker CRP were not reported in the submitted results for either group. It is also worth noting that outcome figures for the control group were not reported in the submitted data for any of the measures listed above, so no comparison between the two groups can be drawn from what was provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03190694 · results posted 17 June 2024

According to the results reported on ClinicalTrials.gov, this trial involved 53 people in total (27 in one group, 26 in the other) who had kidney disease not caused by diabetes and had a certain level of protein in their urine. It was a "crossover" trial, meaning every participant took both the active tablet (dapagliflozin 10 mg) and a dummy tablet (placebo) at different times, with a six-week break in between. The trial was primarily looking at whether dapagliflozin changed the amount of protein leaking into participants' urine over 24 hours, and also tracked kidney filtration rate, blood pressure, body weight, and a urine marker called 6-keto-Prostaglandin F1 Alpha. The reported data shows that for the main measure — change in 24-hour urine protein — the dapagliflozin group showed an average change of about −15%, and the placebo group also showed about −15.8%, meaning both groups showed a similar reduction from their starting levels. For kidney filtration rate (a measure of how well the kidneys are cleaning the blood), the reported average change was −6.3 mL/min per 1.73m² for dapagliflozin compared with +0.3 for placebo, indicating the dapagliflozin group's filtration rate was somewhat lower at the end of treatment. Blood pressure and body weight figures were recorded at multiple time points across both groups, with systolic (top number) blood pressure readings ranging roughly from 120 to 127 mmHg and body weights ranging from approximately 77 to 86 kg across the different groups and time points. The urine marker 6-keto-Prostaglandin F1 Alpha showed similar figures between groups (around 0.117–0.128 pg/mmol). The reported data shows that for the safety measure tracking low blood sugar episodes and serious unwanted health events, zero participants in either group had a low blood sugar episode, and one participant in each group had a serious adverse event (an unexpected health problem considered serious enough to record). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03534284 · results posted 5 February 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 126 people in total across three groups: 43 received a talking-based approach called CBT-I (Cognitive Behavioural Therapy for Insomnia), 42 received a medication called trazodone, and 41 received a placebo (a dummy pill with no active ingredient). The trial was measuring insomnia and sleep-related outcomes at two points in time — around 7 weeks in (short-term) and around 25 weeks in (long-term). The main thing being measured was insomnia severity using a questionnaire called the Insomnia Severity Index, which runs from 0 to 28, where a higher number means worse insomnia. The reported data shows that at the 7-week mark, average insomnia scores were 12.47 for the CBT-I group, 11.97 for the trazodone group, and 13.05 for the placebo group. At 25 weeks, the reported scores were 11.34 for CBT-I, 12.20 for trazodone, and 11.85 for placebo. For the secondary outcomes — which looked at overall sleep quality (scored 0–21, higher is worse) and daytime sleepiness (scored 0–24, higher is worse) — the reported data shows similar patterns across groups at both time points. For example, at 7 weeks the sleep quality scores were 9.44 (CBT-I), 11.09 (trazodone), and 12.39 (placebo), and at 25 weeks they were 9.15, 10.49, and 9.95 respectively. Daytime sleepiness scores were broadly similar across all three groups at both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04985383 · results posted 29 September 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04985383) enrolled 10 participants who all used a single investigational device called the AKST1210 — a type of column added to a standard kidney dialysis (haemodialysis) machine. The trial tested three different column sizes (S-15, S-25, and S-35) at two different blood-flow speeds (250 mL/min and up to 450 mL/min), with each combination used for one week. Nine of the 10 participants completed all six weeks of treatment. The trial was primarily measuring certain safety-related events, as well as how well dialysis was working for each combination of column size and flow speed. The reported data shows that when it came to unexpected medical events (called treatment-emergent adverse events), 1 participant experienced such an event during the S-15 column at 250 mL/min, and 1 participant each had an event during the S-25 at 450 mL/min and S-35 at 450 mL/min settings; no such events were reported for the other three combinations. Regarding a drop in blood pressure during dialysis (called intradialytic hypotension), 1 participant experienced this during the S-15 at 250 mL/min setting, and none were reported for any other combination. The trial also tracked changes in two types of haemoglobin (a protein in red blood cells) in the blood after dialysis. For total haemoglobin, the reported changes ranged from a rise of 4.9 mg/dL (S-15 at 250 mL/min) to a fall of 7.1 mg/dL (S-35 at 450 mL/min). For free haemoglobin (haemoglobin that has leaked out of red blood cells), changes ranged from a rise of 1.5 mg/dL to a rise of 49.0 mg/dL — noting that data for the S-25 combinations were not reported for these haemoglobin measures. The reported data shows that two measures were used to assess how well dialysis was clearing waste from the blood. The first, called Kt/V (a standard calculation of dialysis dose), ranged from 1.2 to 1.8 across the six column-and-flow combinations. The second, called the Urea Reduction Ratio (URR) — which measures the percentage drop in a waste product called urea during a dialysis session — ranged from 55.0% to 77.1% across the different combinations, with higher flow speeds generally showing higher reported values for a given column size. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04696146 · results posted 29 September 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people in total — 21 received a medicine called Berinert and 24 received a placebo (a dummy treatment with no active ingredient). The trial was looking at outcomes after a kidney transplant, specifically whether patients needed dialysis (a machine that does the work of the kidneys) in the first 30 days, how well the transplanted kidney was functioning at six months, and whether the transplanted kidney was still working at six months. The reported data shows that when it came to needing dialysis in the first 30 days, 10 participants in each group required at least one session. For kidney function at six months, the Berinert group had an average eGFR (a measure of how well the kidneys filter the blood — higher numbers generally mean better filtering) of 54, compared with 42 in the placebo group. All 20 participants who completed the study in each group still had a working transplanted kidney at six months. On the secondary measures, rejection episodes (where the body tries to attack the new kidney) by day 180 were recorded in 3 participants in the Berinert group and 0 in the placebo group. One participant in each group developed donor-specific antibodies (proteins the body can make that may target the donated kidney) at six months. Regarding adverse events (any unwanted medical occurrences during the study), 16 out of 20 participants in the Berinert group and 17 out of 20 in the placebo group were reported to have experienced at least one. It is worth noting that a number of participants did not complete the study — 1 in the Berinert group and 4 in the placebo group — and the data does not report the reasons for this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03774394 · results posted 21 August 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people with diabetes — 31 who also had chronic kidney disease (CKD) and 30 who did not. Two participants in the CKD group did not complete the study, so final results were based on 29 and 30 participants respectively. The trial was looking at how well a single 600 mg loading dose of clopidogrel (a blood-thinning medicine) reduced platelet reactivity — that is, how "sticky" blood platelets are — and whether having CKD alongside diabetes made any difference to that response. Platelet reactivity was measured using two different laboratory tests. The reported data shows that the main measure — called the Platelet Reactivity Index (PRI), measured by a test called VASP — came back at 67.5% for the CKD group and 67.2% for the non-CKD group. The trial noted a cut-off of 50% for what it defined as "high platelet reactivity," meaning both groups returned figures above that threshold. A second test (called VerifyNow, measuring PRU units) showed 164 for the CKD group and 156 for the non-CKD group; the cut-off for high reactivity on that test was listed as 208, so both groups came in below it. For the secondary outcome, the reported concentration of the active breakdown product of clopidogrel in the blood was 47.1 ng\*h/mL in the CKD group and 39.6 ng\*h/mL in the non-CKD group. An additional pre-specified test — measuring platelet reactivity after blood was exposed to the active form of clopidogrel directly in the lab — returned very high figures of 92.7% and 94.4% for the two groups respectively; no further explanation of these figures was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02915601 · results posted 25 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02915601) enrolled 109 people — 55 in the sodium bicarbonate group and 54 in the placebo group. Of those, 44 and 46 people respectively completed the study. The trial was measuring changes in blood vessel function and heart-related measures in participants, specifically looking at how flexible and responsive blood vessels were, how fast pulse waves travel through the main artery (a measure of artery stiffness), and the size of the heart's main pumping chamber wall. The reported data shows the following numbers for the two main (primary) measures. For brachial artery flow mediated dilation — a way of measuring how well a blood vessel in the arm widens in response to blood flow — the sodium bicarbonate group recorded values of 3.99% and then 4.25%, while the placebo group recorded 3.78% and then 4.43%. For aortic pulse wave velocity — how quickly a pulse travels along the main artery, where higher numbers suggest stiffer arteries — the sodium bicarbonate group recorded 998.3 cm/sec and then 1067.2 cm/sec, while the placebo group recorded 994.8 cm/sec and then 983.4 cm/sec. The reported data shows that for the secondary measure, left ventricular mass index — a measure of the heart wall's mass relative to body size — the sodium bicarbonate group recorded 57.4 g/m² and then 57.2 g/m², while the placebo group recorded 59.4 g/m² and then 67.6 g/m². It is worth noting that the data as submitted does not clearly label which measurements are "before" and "after" for each group beyond the order in which they appear, so the figures above are described in the sequence they were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04523220 · results posted 21 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04523220) enrolled 704 participants across three groups — a higher-dose osocimab group (234 people), a lower-dose osocimab group (235 people), and a placebo group (235 people). Osocimab is an investigational injectable medicine being studied in people with kidney disease who undergo regular dialysis. The trial was measuring two main things over six months: first, how often participants experienced significant bleeding events; and second, how often participants experienced moderate-to-severe unwanted medical events or serious adverse events (unexpected health problems that occurred during the study, whether or not they were thought to be related to the treatment). The reported data shows that, for the bleeding outcome, 3.57% of participants in the higher-dose osocimab group, 4.32% in the lower-dose group, and 6.09% in the placebo group experienced a significant bleeding event by the six-month mark. For the second main outcome — moderate-to-severe adverse events or serious adverse events — the reported figures were 38.84% in the higher-dose group, 38.37% in the lower-dose group, and 32.17% in the placebo group. The trial also measured two secondary outcomes related to blood markers at six months. A blood clotting time measurement (called aPTT) was on average 1.26 times higher than each person's starting level in the higher-dose group, 1.19 times higher in the lower-dose group, and 1.02 times higher in the placebo group. A measure of a clotting protein called Factor XI showed activity ratios of 0.87, 0.94, and 0.96 compared to baseline for the higher-dose, lower-dose, and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03459807 · results posted 3 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03459807) looked at whether it was practical to run a larger study comparing two different blood pressure targets in people on dialysis. Fifty people were screened, and 50 were enrolled — 25 in a group whose blood pressure was monitored at home (aiming for a reading below 140 mmHg), and 25 in a group whose blood pressure was measured before each dialysis session (also aiming below 140 mmHg). Almost all participants finished the study — 25 in the home monitoring group and 24 in the pre-dialysis group. The reported data shows that, among the home monitoring group, 93% of participants were able to take their blood pressure readings at home and send them through to the research team over the 16-week study period (with 3 people not completing this and 4 only partially doing so). Regarding certain pre-specified events that were tracked across both groups, the reported data shows the following numbers of participants experienced each: low blood pressure after dialysis (below 90 mmHg) — 2 in the home group, 0 in the pre-dialysis group; high blood pressure after dialysis (above 200 mmHg) — 3 vs 2; cramping during dialysis — 13 vs 18; fainting episodes — 1 vs 1; falls — 3 vs 6; and flash fluid on the lungs — 0 vs 0. Dizziness symptoms were listed as a tracked event but figures for that specific item were not reported in the submitted data. The reported data also shows that the average time participants said they needed to recover after a dialysis session was 327 minutes in the home blood pressure monitoring group and 268 minutes in the pre-dialysis monitoring group, averaged across the study visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03645681 · results posted 15 June 2023

According to the results reported on ClinicalTrials.gov, this trial involved 26 participants, all of whom received a device called the InnAVasc AVG — a type of artificial blood vessel graft used to create access for kidney dialysis. The trial was measuring two main things over a six-month period: how many participants' grafts remained open and usable (called "secondary patency"), and how many specific adverse events — that is, unwanted medical occurrences of particular concern — were recorded. The reported data shows that at the six-month mark, 7 out of the 12 participants who were assessed for the primary endpoint had grafts that remained open and had not been abandoned. For context, only 12 of the original 26 participants were included in this primary analysis. Regarding the second main measure, the reported data shows a total of 56 adverse events of special interest were recorded across the group through six months. These included events such as graft infections, clotting, bleeding, and other complications related to the graft — though the data does not break down exactly how many of each type occurred. It is also worth noting that only 1 participant fully completed the study, and only 3 reached the 24-month follow-up point, so results beyond six months are very limited. The reported data shows this was a small, early-stage study and the numbers above reflect what was observed in this particular group of participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04108000 · results posted 24 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04108000) involved 38 people in total — 19 patients with dementia and end-stage kidney disease, paired with 19 "surrogates" (family members or other trusted people who would help make medical decisions on the patient's behalf). Participants were split into two groups: one received a structured conversation programme called SPIRIT-Dementia, and the other received usual care. The trial was measuring things like how well patients and their surrogates agreed on end-of-life care preferences, how much difficulty patients felt when making those decisions, and how confident surrogates felt about making medical decisions on behalf of their loved one. Not everyone completed the trial — in the SPIRIT-Dementia group, 6 out of 9 patients and 6 out of 9 surrogates finished, while in the usual care group, 9 out of 10 patients and 9 out of 10 surrogates finished. The reported data shows a range of numerical scores across the main measures. For agreement between patients and surrogates on care preferences (measured using a tool called the Goals-of-Care Tool, where higher agreement between the pair is the goal), the reported numbers of agreeing pairs varied across time points. For patients' difficulty in decision-making (scored 13–65, where higher means more difficulty), the SPIRIT-Dementia patients scored around 14–15, and the usual care patients scored around 16–17. For surrogates' confidence in making decisions (scored 0–20, where higher means more confident), the SPIRIT-Dementia surrogates scored around 17–18, and usual care surrogates scored around 17–19. For the secondary outcome looking at care decisions such as withdrawing from dialysis or choosing hospice care, the reported data shows that no participants in the SPIRIT-Dementia group made those decisions, while one participant in the usual care group had a "do not resuscitate" order and one chose hospice. For surrogate anxiety and depression scores after bereavement (each scored 0–21, where 0–7 is considered normal), the reported anxiety scores were 2.0 for the SPIRIT-Dementia group and 4.0–7.5 for the usual care group, and depression scores were 7.0 for the SPIRIT-Dementia group and 7.0–9.5 for the usual care group. It is worth noting that some data points for the SPIRIT-Dementia surrogates' anxiety and depression scores were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02251431 · results posted 17 May 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 57 people in total — 29 received a medication called exenatide-extended release, and 28 received a placebo (an inactive dummy treatment). All 57 participants completed the study with no dropouts. The trial was measuring levels of several biological markers — substances found in blood or urine that researchers use to track things like heart stress and kidney stress. These markers were: galectin-3 and ST2 (measured in blood), and NGAL, KIM-1, L-FABP, and IL-18 (measured in urine). Each marker was compared between the exenatide group and the placebo group. The reported data shows the following average levels for each marker. For the blood markers, galectin-3 was reported at around 9,571 pg/ml in the exenatide group and 9,267 pg/ml in the placebo group at one time point, and around 9,539 pg/ml versus 8,099 pg/ml at another time point. For ST2, the reported figures were around 635 pg/ml (exenatide) versus 443 pg/ml (placebo) at one point, and 525 pg/ml versus 535 pg/ml at another. For the urine markers, NGAL was reported at 17.35 versus 18.44 (exenatide vs placebo) at one point and 14.01 versus 24.39 at another; KIM-1 was 0.10 versus 0.13, then 0.13 versus 0.10; L-FABP was 2.61 versus 3.24, then 2.05 versus 3.00; and IL-18 was 1.68 versus 3.48, then 1.96 versus 2.68. The reported data does not include details about whether any differences between the groups were considered statistically meaningful (i.e., unlikely to be due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03141983 · results posted 14 March 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03141983) enrolled 80 people on long-term kidney dialysis — 38 in the anakinra group and 42 in the placebo group. Of those, 30 and 34 respectively completed the study. The trial was measuring two main things: how often serious unwanted medical events occurred, and whether a blood marker called CRP (a protein that can rise when the body is inflamed) changed over 24 weeks of treatment. The reported data shows that serious unwanted medical events occurred at a rate of 2.71 per patient-year in the anakinra group and 2.74 per patient-year in the placebo group. For the CRP blood marker, both groups showed a small reduction over 24 weeks when measured on a mathematical log scale — a change of −0.4 in the anakinra group and −0.2 in the placebo group. Regarding the secondary measures, 3 participants in the anakinra group and 1 in the placebo group had unwanted events that led to them stopping the study treatment. Infections were recorded in 5 participants in the anakinra group and 11 in the placebo group. One participant in the anakinra group had a low white blood cell count (neutropenia), while none did in the placebo group. No participants in either group had a low platelet count (thrombocytopenia). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03358030 · results posted 20 January 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 213 participants in total across four groups. Roughly 53 people were assigned to a placebo (an inactive dummy treatment), and the remaining participants were split across three groups each receiving a different dose of a drug called ISIS 416858 — either 200 mg (53 people), 250 mg (55 people), or 300 mg (52 people). The trial was measuring bleeding events as its main outcome, and also tracked changes in certain blood measurements related to clotting, as well as any unwanted health events that arose during the study. The reported data shows that for the primary outcome — the number of participants who experienced either a major bleed or a clinically relevant non-major bleed (meaning bleeding serious enough to require medical attention, even if not life-threatening) — the numbers were very similar across all groups: 3 people in the placebo group, 2 in the 200 mg group, 3 in the 250 mg group, and 3 in the 300 mg group. The reported data also shows changes in a clotting-related blood protein called Factor XI (FXI): by the later measurement points, FXI activity appeared to fall more in the higher-dose groups (around −14% to −19% change from starting levels) compared with the placebo group (around −1%). Changes in another clotting measure (aPTT, a test of how quickly blood clots) were also recorded but varied across time points and groups. Regarding unwanted health events during the study, the reported data shows that 33 people in the placebo group, 37 in the 200 mg group, 46 in the 250 mg group, and 44 in the 300 mg group experienced at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02572882 · results posted 20 October 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people as a single group (called the "Full Study Cohort"). Eleven participants completed the study and two did not finish. The trial was measuring how much variation occurred in three things across different phases of treatment: the mix of microorganisms in participants' gut (the "microbiome"), the chemical make-up of their stool (the "stool metabolome"), and the chemical make-up of their blood (the "plasma metabolome"). It also tracked gut symptom scores and how well participants tolerated a dietary fibre supplement called p-inulin. The reported data shows that the primary outcomes were measured using distance scores — a way of expressing how different samples were from one another at different time points (a larger number means greater change). For the gut microbiome, the three phase scores were 0.165, 0.175, and 0.210 (measured in "weighted UniFrac distance" units). For the stool chemical profile, the scores were 14.49, 15.70, and 16.77 (Euclidean distance units). For the blood chemical profile, the scores were 9.48, 9.47, and 9.72 (Euclidean distance units). For the secondary outcomes, the reported data shows gut symptom scores (on a scale of 0–45, where higher means more symptoms) ranged from about 3.45 to 6.23 across the eight time points measured. Regarding tolerability of p-inulin, the data shows that no participants stopped taking p-inulin early at any phase, though 3 participants reduced their dose during the p-inulin phase. It is worth noting that the data as submitted does not clearly label which phase each primary outcome measurement corresponds to, so a direct phase-by-phase comparison cannot be made from the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03373461 · results posted 7 October 2022

According to the results reported on ClinicalTrials.gov, this trial tested four different twice-daily doses of an investigational medicine called LNP023 (10 mg, 50 mg, 100 mg, and 200 mg) against a dummy treatment (placebo) in people with a kidney condition. The trial ran in two parts. In Part 1, a total of 46 people started and all of them completed it. In Part 2, 66 people started, and 64 completed it (one person in the 50 mg group and one in the placebo group did not finish). The main thing being measured was the amount of protein leaking into the urine — specifically a measurement called the urine protein-to-creatinine ratio (UPCR) — after 90 days of treatment. A lower ratio compared to the starting point was considered a reduction in protein leakage. The reported data shows that after 90 days, the UPCR ratio compared to each participant's own starting level was: 0.85 for the 10 mg group, 0.80 for the 50 mg group, 0.76 for the 100 mg group, 0.69 for the 200 mg group, and 0.88 for the placebo group. A number below 1.0 means the level was lower than at the start; a ratio of 0.69, for example, means the 200 mg group's average reading was about 69% of what it was at the beginning. The reported data also shows results for several secondary measurements. Kidney filtration (eGFR, a measure of how well the kidneys are filtering blood) changed from baseline by −0.06, +2.49, +0.23, +2.42, and −3.34 units for the 10 mg, 50 mg, 100 mg, 200 mg, and placebo groups respectively. A blood waste product called serum creatinine changed by −2.55, −2.60, +0.76, −3.47, and +6.65 units (µmol/L) for those same groups. Ratios for total urine protein and urine albumin (another protein) also showed values below 1.0 across most dose groups and the placebo group, meaning levels were generally lower than at baseline across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03799627 · results posted 29 September 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people in total across nine groups. Participants were kidney disease patients already receiving a medicine called epoetin alfa (an injected treatment for anaemia — low red blood cell levels). The trial was comparing different doses of a tablet called vadadustat against continued epoetin alfa injections. Participants were divided based on how they had been responding to their existing epoetin alfa dose — those on a low dose, those on a high dose, and those whose bodies were not responding well to it (called "ESA hyporesponders"). The main things being measured were changes in haemoglobin levels (a protein in red blood cells that carries oxygen — used here as a marker of anaemia), as well as medical events that occurred during the trial, changes in blood test results, changes in vital signs like blood pressure and heart rate, and whether haemoglobin levels moved outside a safe range. The reported data shows that haemoglobin levels at the start of the study ranged from roughly 9.5 to 10.3 g/dL (grams per deciliter — a standard unit for measuring haemoglobin) across the different groups. Complete change-from-baseline figures were only reported for three of the nine groups: in the "Low Dose" category, the vadadustat 300 mg group showed an average change of −0.371 g/dL (a small decrease), the vadadustat 450 mg group showed +0.072 g/dL (roughly no change), and the epoetin alfa group showed +0.160 g/dL. Change figures for the remaining six groups were not reported in the submitted data. For the secondary outcome of how many participants had haemoglobin within the target range of 10.0–11.0 g/dL at weeks 10–12, the reported numbers ranged from 0 participants (in both ESA hyporesponder groups) up to 15 participants in the Low Dose epoetin alfa comparison group. Regarding medical events that arose during treatment, the numbers of participants who experienced at least one such event ranged from 3 (in the ESA hyporesponder epoetin alfa group of 5 people) to 27 (in the Low Dose vadadustat 450 mg group of 34 people). The reported data shows that no participants in any group were recorded as having clinically significant changes in blood test results or vital signs. Small numbers of participants in some groups were classified as haemoglobin "outliers" — meaning their levels moved outside the pre-set safe boundaries — with the highest number being 3 participants in the Low Dose epoetin alfa group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01906489 · results posted 1 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT01906489) enrolled 210 participants in total — 138 received vadadustat and 72 received a placebo (an inactive dummy treatment). The trial was measuring whether vadadustat could raise participants' haemoglobin levels (a measure of red blood cells in the blood) to a target range, in people who had anaemia related to chronic kidney disease. Of those who started, 112 in the vadadustat group and 63 in the placebo group completed the study. The reported data shows that for the main (primary) goal — reaching a haemoglobin level of at least 11.0 g/dL, or increasing it by at least 1.2 g/dL by weeks 19–20, without needing rescue treatments — about 54.9% of people in the vadadustat group met this target, compared with about 10.3% in the placebo group. For the secondary outcomes, the reported data shows that 59.6% of people in the vadadustat group had haemoglobin reach or exceed 13.0 g/dL at some point during the study (which the trial counted as an unwanted excursion), compared with 88.9% in the placebo group. When the response was assessed purely by haemoglobin level — without counting rescue treatment as an automatic "failure" — 44.9% of the vadadustat group and 13.9% of the placebo group met the target. The reported data also shows response rates broken down by prior treatment history: among those who had never had a related treatment before, 50% (vadadustat) vs 7.9% (placebo) met the target; among those previously treated, 41.5% vs 19%; and among those actively being treated at the start, 33.3% vs 7.7%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01381094 · results posted 1 July 2022

According to the results reported on ClinicalTrials.gov, this trial tested four different daily oral doses of an experimental drug called AKB-6548 (240 mg, 370 mg, 500 mg, and 630 mg) compared to a placebo (a dummy tablet with no active ingredient) in people with anaemia — a condition where the blood carries less oxygen than normal, often linked to kidney disease. A total of 91 people started the trial across the five groups, with numbers ranging from 17 to 19 per group. Most participants completed the six-week treatment period, with between 15 and 18 people finishing in each group. The main thing the trial measured was the change in haemoglobin levels (haemoglobin is the protein in red blood cells that carries oxygen) from the start of the trial to the end of six weeks of treatment. The reported data shows that participants in the placebo group had an average haemoglobin starting level of about 9.83 g/dL (grams per decilitre, a standard unit for measuring haemoglobin in blood), and their level changed by –0.03 g/dL by week six — meaning it stayed roughly the same. In the four AKB-6548 dose groups, starting levels were similar (ranging from about 9.46 to 9.93 g/dL), and the reported changes by week six were +0.77 g/dL (240 mg), +0.73 g/dL (370 mg), +1.25 g/dL (500 mg), and +1.43 g/dL (630 mg). The trial also tracked other blood measurements over time, including haematocrit (the percentage of red blood cells in the blood), red blood cell count, and reticulocyte count (a measure of newly made red blood cells). The reported data shows modest increases in these values across the AKB-6548 groups over the study period, while the placebo group's values remained relatively stable. It is worth noting that not all time-point data for the secondary measures was fully reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02892149 · results posted 28 June 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02892149) enrolled 1,777 people in each group — one group received vadadustat and the other received darbepoetin alfa, which is an already-approved treatment for anaemia related to chronic kidney disease. Around 1,420–1,425 people in each group completed the study. The trial was measuring two main things: changes in haemoglobin levels (a measure of red blood cell activity, reported in grams per deciliter, or g/dL) and the time until a participant experienced a serious heart or stroke-related event, known as a "major adverse cardiovascular event" or MACE (which included death from any cause, a non-fatal heart attack, or a non-fatal stroke). The reported data shows that, on average, haemoglobin levels rose from the starting point in both groups during the main measurement window (weeks 24 to 36). The vadadustat group showed an average increase of 0.19 g/dL, while the darbepoetin alfa group showed an average increase of 0.36 g/dL. In a later measurement window (weeks 40 to 52), the reported increases were 0.23 g/dL for vadadustat and 0.41 g/dL for darbepoetin alfa. For the cardiovascular safety measure, the reported median time to a first serious heart or stroke-related event was approximately 48.86 weeks in the vadadustat group and 48.00 weeks in the darbepoetin alfa group. For a broader combined event measure (which also included hospitalisation for heart failure or certain blood clot events), the reported median times were 43.29 weeks and 45.21 weeks respectively. The reported data also shows figures for additional secondary measures. The median time to a first cardiovascular-specific serious event (counting only deaths confirmed as cardiovascular in cause, plus non-fatal heart attacks and strokes) was reported as 44.57 weeks for vadadustat and 43.57 weeks for darbepoetin alfa. The median time to a first cardiovascular death specifically was reported as 46.14 weeks for vadadustat and 47.64 weeks for darbepoetin alfa. These figures represent the midpoint of when events occurred across participants, and it is worth noting that the trial was designed to combine these cardiovascular results with a companion study (NCT02865850) for a fuller analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02680574 · results posted 27 June 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02680574) enrolled 862 people in the vadadustat group and 863 people in the darbepoetin alfa group — a total of 1,725 participants. Both vadadustat and darbepoetin alfa are treatments being investigated for anaemia (low red blood cell levels) in people with chronic kidney disease. The trial was measuring two main things: changes in haemoglobin levels (a protein in red blood cells that carries oxygen — higher levels generally indicate less anaemia) over time, and how long it took for participants to experience serious heart or stroke-related events. The reported data shows that, for the primary measure of haemoglobin change from the start of the study to the period covering weeks 24 to 36, the vadadustat group showed an average increase of 0.41 grams per deciliter (g/dL), while the darbepoetin alfa group showed an average increase of 0.42 g/dL. For the secondary haemoglobin measure covering weeks 40 to 52, the reported figures were 0.43 g/dL and 0.44 g/dL respectively. Regarding serious heart and stroke-related events (called MACE — meaning death from any cause, heart attack, or stroke), the reported median time to a first such event was approximately 53 weeks in the vadadustat group and 58 weeks in the darbepoetin alfa group. For a broader category that also included hospitalisation for heart failure or blood clot events, the reported median times were approximately 48 weeks and 49 weeks respectively. The reported data also shows figures for two further secondary measures. For cardiovascular-specific serious events (counting only deaths confirmed as heart-related, plus heart attacks and strokes), the median time to a first event was reported as approximately 46 weeks for vadadustat and 50 weeks for darbepoetin alfa. For cardiovascular death alone, the reported median times were approximately 48 weeks and 54 weeks respectively. These figures come from this single study; the trial notes that the heart-event safety analysis was also designed to be combined with a companion study for a broader pooled analysis, the results of which were reported separately. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03213158 · results posted 11 May 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people who were described as "highly sensitised" kidney transplant candidates — meaning they had a high level of antibodies in their blood that make it very difficult to find a compatible donor kidney. The trial was testing a medicine called ixazomib to see whether it could reduce those antibody levels and improve participants' chances of receiving a kidney transplant. Of the 10 people who started the trial, 7 completed it and 3 did not. The reported data shows that for the two main things the trial was measuring, the results were as follows. First, none of the 10 participants had a reduction of more than 20% in their antibody levels (measured using something called "calculated Panel Reactive Antibody," or cPRA — essentially a score reflecting how hard it is to find a matched donor). Second, 2 out of 10 participants went on to receive a kidney transplant within 12 months. For the additional tracked outcomes, the reported data shows that 2 participants had cardiovascular (heart and blood vessel) complications within 12 months, 2 participants had blood-related complications (such as low white blood cell, red blood cell, or platelet counts), no participants developed any cancers, and 5 participants experienced gastrointestinal symptoms (such as stomach or digestive issues) within 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03422653 · results posted 26 April 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03422653) looked at a drug called CR845 (also written as difelikefalin) as a treatment for itch in people receiving haemodialysis. In the first, blinded phase — where neither participants nor researchers knew who received which treatment — 189 people were given CR845 and 189 were given a placebo (a dummy treatment). In the second, open-label phase, where everyone knew they were receiving CR845, 313 participants took part. The trial's main focus was measuring how much participants' itch intensity improved over 12 weeks, using a simple 0–10 self-reported scale (where 0 means no itch and 10 means the worst itch imaginable). The reported data shows that, for the main outcome, 51.0% of people in the CR845 group had their worst daily itch score drop by 3 or more points on that 0–10 scale by week 12, compared with 27.6% of people in the placebo group. For a stricter measure — a drop of 4 or more points — the reported data shows 38.9% in the CR845 group compared with 18.0% in the placebo group. Two questionnaires were also used to measure how itch affected daily life and wellbeing. The reported data shows that scores on the 5-D Itch Scale (which runs from 5 to 25, with higher meaning worse) fell by an average of 5.0 points in the CR845 group and 3.7 points in the placebo group. On the Skindex-10 questionnaire (which runs from 0 to 60, with lower meaning better quality of life), scores fell by an average of 17.2 points in the CR845 group and 12.0 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03636269 · results posted 26 April 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03636269) enrolled people who experienced chronic itch, and tested a drug called CR845 (at a dose of 0.5 micrograms per kilogram of body weight) against a placebo (an inactive treatment). In the first, blinded phase — where neither participants nor researchers knew who received which treatment — 235 people received CR845 and 236 received placebo. The trial's main goal was to measure how many people in each group reported their itch score dropping by at least 3 points on a 0–10 scale (where 0 means no itch and 10 means the worst itch imaginable) after 12 weeks. A second, open-label phase (where everyone knew they were receiving CR845) involved 399 participants, though only 5 completed it. The reported data shows that for the primary outcome at 12 weeks, 54.0% of people in the CR845 group achieved a drop of 3 or more points in their worst daily itch score, compared with 42.2% in the placebo group. For a stricter measure — a drop of 4 or more points — the reported data shows 41.2% in the CR845 group reached that threshold, compared with 28.4% in the placebo group. Two quality-of-life questionnaires were also measured. On the Skindex-10 (a 0–60 scale where lower scores mean better quality of life), the CR845 group's average score changed by −16.6 points from the start, while the placebo group's changed by −14.8 points. On the 5-D Itch Scale (a 5–25 scale where lower scores mean better outcomes), the CR845 group changed by −4.9 points on average, compared with −3.8 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02876835 · results posted 14 April 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT02876835) enrolled 3,872 people in total — 1,937 in the daprodustat group and 1,935 in the darbepoetin alfa group. Both groups went through a short run-in period before starting roughly four years of treatment. The trial was designed to measure two main things: whether daprodustat was no worse than darbepoetin alfa in terms of serious heart and blood vessel events (such as death from any cause, heart attack, or stroke), and how each treatment affected haemoglobin levels (haemoglobin is a protein in red blood cells that carries oxygen around the body). The reported data shows that the rate of first serious cardiovascular events — counted as events per 100 years of follow-up across all participants — was 10.86 for the daprodustat group and 10.63 for the darbepoetin alfa group. For haemoglobin levels, the average change from the starting level over the measurement window (weeks 28 to 52) was +0.74 grams per decilitre in the daprodustat group and +0.66 grams per decilitre in the darbepoetin alfa group. The reported data also shows secondary outcome rates per 100 person-years: for MACE or a blood clot event, 12.34 versus 11.77; for MACE or hospitalisation for heart failure, 13.16 versus 12.22; and for kidney disease progression, 17.55 versus 17.76, in the daprodustat and darbepoetin alfa groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01244763 · results posted 10 February 2022

According to the results reported on ClinicalTrials.gov, this trial tested a medicine called roxadustat, given to adults across six different dosing groups (labelled Cohorts A through F). Each group had either 24 or 25 participants at the start, giving a total of 145 people. The groups differed in how much roxadustat was given and how often — some received it three times a week, some twice a week, and some started on one schedule before switching to another. The main thing the trial was measuring was whether participants' haemoglobin (Hb) level — a measure of red blood cells in the blood — reached a certain target by Week 17. The target was defined as an Hb level of at least 11 g/dL (grams per decilitre, a standard unit for measuring substances in blood) and a rise of at least 1 g/dL from where it started. The reported data shows that, by Week 17, the number of participants whose Hb met that target in each group was: 19 out of 23 in Cohort A, 24 out of 24 in Cohort B, 21 out of 23 in Cohort C, 23 out of 24 in Cohort D, 23 out of 24 in Cohort E, and 21 out of 25 in Cohort F. For the secondary measurements — which tracked Hb levels at earlier and later time points — the reported data shows that at Week 5, fewer participants had reached the Hb target (ranging from 3 in Cohort C to 15 in Cohort A), with numbers generally rising by Week 9. The average starting Hb across all groups was roughly 9.6–9.9 g/dL, and by Week 5, the reported average increase from that starting point ranged from about 0.57 g/dL in Cohort C to about 1.71 g/dL in Cohort A. Full data for all later time points (Weeks 13, 21, and 25) was not completely reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03194321 · results posted 30 December 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people who had received a kidney transplant and were described as "highly sensitised" — meaning their immune systems had developed a strong response that made finding a compatible donor kidney more difficult. All participants received a once-daily, extended-release form of a medicine called tacrolimus (used to help prevent the body from rejecting a transplanted organ) alongside a pre-transplant treatment programme. Of the 20 people who started, 17 completed the study and 3 did not. The reported data shows that the primary outcome measured two things: serious unwanted medical events thought to be related to the treatment, and what the researchers called "treatment failure" — a combined measure covering rejection of the kidney confirmed by biopsy, loss of the transplanted kidney, or death. The numbers reported show 2 participants experienced serious adverse events, 2 experienced biopsy-confirmed rejection, 1 experienced graft (transplant) failure, 1 died, and 4 met the combined "treatment failure" definition. For a secondary outcome, the trial tracked levels of donor-specific antibodies — proteins the immune system makes that can target a donated organ — using a scoring system where a higher score indicates more of these antibodies. The reported data shows the average score started at 3.21 and was recorded at various follow-up points as 0.79, 0.64, 0.93, 0.86, and 1.14. A separate secondary measure found that 3 participants stopped taking the study medication during the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02879305 · results posted 3 December 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02879305) enrolled 2,964 people in total — 1,487 in the daprodustat group and 1,477 in the rhEPO (a comparator injection medicine) group. The trial was measuring two main things: whether daprodustat was no worse than rhEPO when it came to serious cardiovascular events (such as death from any cause, heart attack, or stroke), and how much each treatment changed participants' haemoglobin levels (a measure of red blood cells in the blood) over a set period between weeks 28 and 52 of the study. Around 1,370 participants in the daprodustat group and 1,366 in the rhEPO group completed the trial. The reported data shows that serious cardiovascular events were measured as a rate — roughly how many events occurred per 100 person-years (a way of accounting for how long people were followed up). For daprodustat, the reported rate was 11.07 events per 100 person-years, compared with 11.86 for rhEPO. For haemoglobin levels, the reported average change from the starting measurement was an increase of 0.28 grams per decilitre in the daprodustat group, compared with 0.10 grams per decilitre in the rhEPO group. The reported data also shows several secondary (additional) measurements. When combining serious cardiovascular events with blood clot-related events, the reported rates were 15.84 (daprodustat) versus 17.85 (rhEPO) per 100 person-years. When combining serious cardiovascular events with hospital admissions for heart failure, the rates were 12.98 versus 13.38 per 100 person-years. The average monthly intravenous iron dose used was reported as 90.8 milligrams for daprodustat and 99.9 milligrams for rhEPO. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03029208 · results posted 20 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03029208) enrolled 312 people on kidney dialysis — 157 in the daprodustat group and 155 in the darbepoetin alfa group (an existing injectable medicine used to manage anaemia in dialysis patients). The trial was primarily measuring changes in haemoglobin levels — that is, the amount of oxygen-carrying protein in the blood — over a period roughly between week 28 and week 52 of the study. Several secondary measurements were also tracked, including intravenous (IV) iron use and blood pressure readings. The reported data shows that, for the primary measure, haemoglobin levels rose from the starting point by an average of 1.02 grams per deciliter in the daprodustat group, and by 1.12 grams per deciliter in the darbepoetin alfa group. For the secondary measures, the average monthly IV iron dose was reported as 144.7 milligrams in the daprodustat group and 125.3 milligrams in the darbepoetin alfa group. Regarding blood pressure at week 52, the top number (systolic) changed by −3.57 mmHg (daprodustat) and −6.80 mmHg (darbepoetin alfa); the bottom number (diastolic) changed by +0.21 mmHg and −4.01 mmHg respectively. Blood pressure "exacerbation events" — defined as notably large rises or high readings — occurred at a rate of about 352.5 per 100 participant-years in the daprodustat group and 350.0 in the darbepoetin alfa group, with 91 and 100 participants respectively experiencing at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01750190 · results posted 1 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT01750190) looked at a medicine called roxadustat compared to a placebo (an inactive dummy treatment) in people with anaemia linked to chronic kidney disease who were not on dialysis. A total of 616 people were assigned to roxadustat and 306 to placebo — around 922 participants in all. The main things being measured were changes in haemoglobin levels (haemoglobin is a protein in red blood cells that carries oxygen around the body — low levels indicate anaemia) over the course of the study, as well as how many participants reached a target haemoglobin level within the first 24 weeks. The reported data shows that, at the start of the study, average haemoglobin levels were similar in both groups (around 9.10 g/dL). For the primary outcome used in the US regulatory submission, the roxadustat group showed an average increase in haemoglobin of 2.00 g/dL from their starting level (measured across weeks 28 to 52), while the placebo group showed an average increase of 0.16 g/dL over the same period. For the primary outcome used outside the US, 523 out of 608 participants in the roxadustat group reached the target haemoglobin response within the first 24 weeks (without needing rescue treatments such as blood transfusions), compared with 20 out of 305 in the placebo group. Among the secondary outcomes, 467 roxadustat participants compared to 56 placebo participants had haemoglobin levels at or above 10 g/dL averaged across weeks 28 to 36. The reported data also shows that LDL cholesterol (a type of fat in the blood) changed on average by −18.48 mg/dL in the roxadustat group and +0.22 mg/dL in the placebo group between weeks 12 and 28. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02314403 · results posted 2 September 2021

According to the results reported on ClinicalTrials.gov, this trial involved just 2 participants, both of whom completed the study. The trial was looking at a procedure that combined a bone marrow transplant with a kidney transplant. The key question being measured was whether participants could eventually stop taking immunosuppression medications — the drugs normally needed after a transplant to stop the body rejecting the new organ — and remain off those medications for 24 months in a row. The reported data shows that both participants (2 out of 2) met this primary outcome — meaning both were reported to have gone 24 consecutive months without needing immunosuppression medications. Because this trial was very small, with only 2 people enrolled, the numbers on their own are limited in what they can tell us about how the procedure might perform more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02258074 · results posted 30 July 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 205 people across four groups. Each group received a different combination of two treatments — lanthanum carbonate (a phosphate binder) and nicotinamide (a form of vitamin B3) — or placebo versions of one or both. The trial ran for 12 months and was measuring changes in two things in the blood: levels of a hormone called FGF23 (which is involved in how the body manages phosphate and kidney health) and levels of phosphate itself. The reported data shows the changes from the start of the trial to the 12-month mark. For FGF23 levels (measured in pg/ml, a standard unit of concentration), the group taking both active treatments showed a change of +0.047, the group taking lanthanum carbonate with a nicotinamide placebo showed −0.003, the group taking nicotinamide with a lanthanum carbonate placebo showed +0.193, and the group taking both placebos showed +0.138. For blood phosphate levels (measured in mg/dl), the reported changes were +0.06 for the two groups involving lanthanum carbonate (with or without active nicotinamide) and +0.12 for the two groups that did not receive active lanthanum carbonate. Only one participant across all groups did not complete the study. It is worth noting that the reported data shows only the raw numerical changes in these measurements across the four groups; no additional context about what those differences mean clinically was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03402386 · results posted 6 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03402386) tested a treatment called MT-6548 in 42 people. The trial was measuring levels of haemoglobin (Hb) — a protein in red blood cells that carries oxygen around the body — in people with anaemia related to kidney disease. Of the 42 participants who started, 40 were in a group aiming to raise their haemoglobin to a target range ("Conversion Group"), and 2 were in a group already working to maintain their levels ("Correction Group"). By the end of the study, 36 participants had completed it, and 6 did not finish. The reported data shows that the main result — the average haemoglobin level measured across weeks 20 and 24 — was 11.35 grams per decilitre (g/dL), which is a standard unit for measuring haemoglobin in blood. The reported data also shows haemoglobin readings taken at various individual time points throughout the study, which ranged from approximately 10.61 g/dL to 11.68 g/dL. When looking at how many participants had haemoglobin levels within the target range at each time point, the reported figures ranged from about 32% to 67% of participants, depending on the time point. For the two participants in the Correction Group, the data on how quickly they reached the target range and how fast their haemoglobin levels rose was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03197038 · results posted 2 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03197038) enrolled 39 older adults with kidney disease who also had early signs of cognitive (thinking and memory) difficulties. Twenty-two participants were assigned to a home-based walking exercise program and 17 were assigned to a control group (no exercise program). The trial ran for 6 months and was measuring whether the walking program had any effect on thinking and memory abilities, as well as several measures of brain health, including the structure of brain connections, the size of a memory-related brain region, blood flow to the brain, and the stiffness of a major neck artery. Eighteen of the 22 people in the exercise group completed the study, while all 17 in the control group completed it. The reported data shows that for the two main outcomes — overall thinking ability and a specific area called "executive function" (skills like planning and mental flexibility) — both groups showed small changes from the start of the trial to the end. The exercise group's overall thinking score changed by +0.15 (on a standardised scale) compared to +0.02 for the control group, and for executive function the exercise group changed by +0.21 compared to −0.01 for the control group. For the secondary (additional) measures, the reported changes were generally small across both groups. Brain connection integrity showed a change of −0.002 in the exercise group and +0.003 in the control group. The right hippocampus (a brain region linked to memory) showed an identical reported change of +0.003 cubic millimetres in both groups. Brain blood flow changed by +1.6 mL/100g/min in the exercise group versus +0.3 in the control group. Artery stiffness, where a larger negative number suggests a less stiff artery, changed by −3,175 kilopascals in the exercise group and +1,279 kilopascals in the control group. No information about whether these differences were statistically meaningful (i.e., unlikely to be due to chance) was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03029247 · results posted 3 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03029247) enrolled 88 participants in total — 45 in the daprodustat group and 43 in the recombinant human erythropoietin (a type of injectable medicine already used to manage anaemia in kidney disease) group. The trial was measuring how the two treatments compared in terms of their effect on blood pressure and heart rate, tracked using a device worn to monitor blood pressure continuously over several hours. Participants went through an initial dosing session on Day 1, an eight-week maintenance period, and then a second dosing session on Day 57. Not everyone completed the maintenance phase — 13 people in the daprodustat group and 7 in the erythropoietin group did not finish that stage, though the data does not specify why. The reported data shows that the main outcome — average top-number blood pressure (systolic blood pressure) measured over six hours after dosing on Day 57 — was 142.87 mmHg (millimetres of mercury, the standard unit for blood pressure) in the daprodustat group and 143.03 mmHg in the erythropoietin group. For the secondary outcomes measured on Day 1 over six hours, the reported figures were: systolic blood pressure 141.36 mmHg (daprodustat) versus 142.68 mmHg (erythropoietin); bottom-number blood pressure (diastolic) 75.97 versus 77.92 mmHg; and average arterial pressure 99.18 versus 101.58 mmHg. Heart rate over six hours on Day 1 was reported as 70.77 beats per minute for daprodustat and 73.72 for erythropoietin. Similar patterns were seen in the Day 57 diastolic and average arterial pressure readings, and in the 24-hour cumulative blood pressure and heart rate calculations on Day 1. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02351349 · results posted 26 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02351349) enrolled 14 people in total — 6 in the intervention group (who received a multi-part program) and 8 in the control group. By the end of the study, 4 people in the intervention group and 5 in the control group had completed it, with 2 and 3 people respectively not finishing. The trial was measuring a range of things in people with chronic kidney disease, including deaths, whether participants went on to need kidney replacement therapy (such as dialysis), hospitalisations, and several measures of physical ability. The reported data shows that, for the three main outcomes of death, progression to kidney replacement therapy, and hospitalisations, the recorded figure was zero participants in both groups across all of these measures. For the physical functioning tests, two sets of measurements appear to have been recorded (likely at different time points, though the data does not label these clearly). For the 4-metre walk test — where a lower time in seconds suggests faster walking — the intervention group recorded 5 seconds then 3.9 seconds, while the control group recorded 5.3 seconds then 5.5 seconds. For the "Timed Up and Go" test (where a person stands from a chair, walks a short distance, and returns), the intervention group recorded 12 seconds then 10.8 seconds, compared to 13 seconds then 13.3 seconds in the control group. For hand grip strength, the intervention group recorded 23 kg then 26.5 kg, while the control group recorded 19 kg then 20 kg. It is worth noting that the overall number of participants in this trial was very small, and the reported data does not include full details about the timing of measurements or any statistical analysis comparing the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03161158 · results posted 5 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03161158) enrolled 37 people in total — 18 in the ultrafiltration group and 19 in the usual care group, which received standard intravenous (IV) diuretic medicines. The trial was looking at two main things over a 90-day follow-up period: how many participants had a heart failure event (meaning a hospital stay or an unplanned visit to a clinic or emergency department needing IV treatment for heart failure), and how many participants died from a cardiovascular (heart or blood vessel-related) cause. Not everyone completed the study — 9 out of 18 in the ultrafiltration group and 13 out of 19 in the usual care group finished. The reported data shows that for heart failure events, 4 participants in the ultrafiltration group and 4 participants in the usual care group experienced this outcome. For cardiovascular deaths within 90 days, the reported data shows 4 participants in the ultrafiltration group and 1 participant in the usual care group. The trial did not report any additional detail beyond these participant counts, so no further breakdown of these numbers is available from the submitted results. It is worth noting that this was a small study with relatively few participants finishing in each group, which the data itself reflects but does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03236246 · results posted 12 March 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 206 adults in total — 104 in a group starting on a lower daily dose of a treatment called KRX-0502 (3 g per day) and 102 in a group starting on a higher dose (4 g per day). The trial was split into two back-to-back periods: a 24-week dose adjustment phase, followed by a 24-week dose maintenance phase, running for about 48 weeks in total. The main thing being measured was any change in haemoglobin levels — haemoglobin is the protein in red blood cells that carries oxygen around the body, and low levels are a sign of anaemia. The trial also tracked iron-related measurements in the blood, including transferrin saturation (a measure of how much iron is being carried in the blood) and ferritin (a measure of iron stored in the body). The reported data shows that at the 24-week mark (the primary outcome), average haemoglobin levels had risen by 0.73 g/dL (grams per decilitre, a standard unit for blood measurements) in the 3 g/day group and by 0.70 g/dL in the 4 g/day group compared to where they started. At 48 weeks, the reported rises were 0.61 g/dL and 0.58 g/dL respectively. The reported data also shows that the estimated time for a participant's haemoglobin to first rise by at least 0.5 g/dL was 84 days in the 3 g/day group and 57 days in the 4 g/day group. For the iron-related measures, transferrin saturation was reported to have risen by around 6.30 percentage points (3 g/day group) and 6.85 percentage points (4 g/day group) at week 24, and by 7.97 and 10.63 percentage points respectively at week 48. Ferritin levels at week 24 were reported to have increased by an average of 136.63 ng/mL in the 3 g/day group and 155.28 ng/mL in the 4 g/day group. Ferritin data at week 48 was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03812679 · results posted 5 February 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03812679) involved a single group of 22 participants who used the AMIA APD Solution Generation System — a device designed to automatically prepare dialysis fluid (the liquid used in a type of kidney dialysis done at home). Of the 22 who started, 14 completed the trial and 8 did not. The trial was measuring whether the fluid the device produced met required quality standards for chemical makeup, water purity, and sterility (freedom from bacteria and other contaminants), as well as tracking a measure of how well the dialysis was working, called Kt/V (a way of estimating how much waste was being cleared from the blood). The reported data shows the following for the quality tests carried out at multiple visits: For the chemical composition of the final dialysis fluid, between about 86% and 95% of tests met the required specifications across the four visits. For the purity of the water before the final sterilising filters, the percentage of tests meeting specifications ranged from around 38% at the first visit up to about 79% by the third visit, with some tests not meeting specifications at each visit. For the water after the sterilising filters (checked for bacteria and related contamination), 100% of tests met specifications at the first two visits, dropping to about 93% and then 86% at the third and fourth visits. The reported data shows that for the dialysis adequacy measure (Kt/V), the average change from the start of the study was −0.15, meaning the recorded value was slightly lower than at baseline, though the clinical meaning of this figure is not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00874432 · results posted 23 September 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people across four groups: 8 people with chronic kidney disease (CKD) who were given an ACE-inhibitor medication, 4 people with CKD who were not given the medication, 17 people without CKD who were given the ACE-inhibitor, and 14 people without CKD who were not given it. Not everyone finished the study — by the end, 5, 2, 9, and 11 people respectively completed it in each group. The trial was measuring "aortic pulse wave velocity" (PWV) — a way of gauging how stiff the large blood vessels are, where a higher number in metres per second generally indicates stiffer vessels — comparing people with CKD to people without CKD, and looking at whether an ACE-inhibitor medication made any difference. The reported data shows the following PWV readings for the primary outcome (comparing the CKD group to the age-matched control group without CKD): three separate measurements were recorded, coming in at 9.90 m/s and 9.96 m/s, then 7.62 m/s and 8.57 m/s, and finally 9.03 m/s and 8.38 m/s respectively. For the secondary outcome looking at vascular stiffness across all four groups at different points and using different measurement routes (carotid-femoral, carotid-brachial, and carotid-radial), the reported data shows a range of readings broadly sitting between approximately 4.80 m/s and 9.75 m/s across the groups and time points. The data submitted does not include labels clearly distinguishing which specific reading corresponds to which time point or measurement route, so a more detailed breakdown cannot be provided here without risking misrepresentation. The reported data shows that no numbers were submitted for the secondary outcome measuring change in blood pressure from the start of the study to 12 months — this information was not reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02031770 · results posted 22 September 2020

According to the results reported on ClinicalTrials.gov, this trial involved 20 people split into two groups of 10. It used a "crossover" design, meaning each person received both the treatment and a control (comparison) condition at different times, with a two-week break in between. Each phase lasted six weeks. By the end of the trial, 18 of the 20 participants had completed the study — one person from each group did not finish. The trial was measuring changes in something called brachial artery flow mediated dilation, or FMD — this is a way of assessing how well a blood vessel in the arm widens in response to increased blood flow, and is used as a measure of blood vessel function. The reported data shows that the main outcome — the change in FMD score — differed between the treatment and control conditions. In the treatment condition, the average FMD changed by +1.1 percentage points, meaning it increased slightly. In the control condition, the average FMD changed by −0.7 percentage points, meaning it decreased slightly. No other outcome measures appear to have been submitted to ClinicalTrials.gov, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03283098 · results posted 10 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 33 participants in total — 8 received a placebo and 25 received the study drug, etelcalcetide. All 8 placebo participants and 24 of the 25 etelcalcetide participants completed the study (one person in the etelcalcetide group did not finish). The trial was primarily measuring how the drug moves through the body over time — specifically how quickly it reaches its peak level in the blood, how high that peak level was, and how much of the drug was present in the blood between doses on the first and last day of dosing (Day 1 and Day 27). The reported data shows that, for participants receiving etelcalcetide, the drug reached its highest blood concentration at around 0.22 hours after dosing on both Day 1 and Day 27. The reported peak blood concentration was 216 ng/mL (nanograms per millilitre, a measure of how much drug is in the blood) on Day 1 and 236 ng/mL on Day 27. The total amount of drug measured in the blood between doses was reported as 1,110 on Day 1 and 3,310 on Day 27 (in units of hour×ng/mL). The trial also calculated an "accumulation ratio" — a number showing how much the drug built up in the body by Day 27 compared to Day 1 — which was reported as 3.02, meaning roughly three times as much drug was present by the end of the dosing period. No figures were reported for the placebo group for these drug-level measurements, as placebo contains no active drug. The reported data also includes information on adverse events (unwanted health events that occurred during the trial). In the etelcalcetide group, 25 out of 25 participants experienced at least one adverse event during the trial period, compared with 7 out of 8 in the placebo group. Five participants in the etelcalcetide group and none in the placebo group experienced what were classified as serious adverse events. One participant in the etelcalcetide group experienced a Grade 3 adverse event (described as medically significant). The data also notes that 5 participants in the etelcalcetide group experienced a category of adverse events described as events of interest related to low calcium levels, and 2 experienced events categorised as infusion reactions; none were reported in the placebo group for these categories. These numbers describe what was recorded and counted — they do not indicate the cause or meaning of these events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02809183 · results posted 14 January 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02809183) enrolled 135 people across six groups. Participants received either a placebo (a dummy treatment with no active ingredient) or one of several doses of a substance called TRC101, taken either twice a day (BID) or once a day (QD). All 135 people who started the trial completed it. The trial was measuring two main things: how many participants experienced unwanted health events during the study (called treatment-emergent adverse events, or TEAEs — essentially any new or worsening health issue that appeared after starting the study treatment), and how levels of a substance in the blood called bicarbonate changed over 15 days. Bicarbonate levels in the blood are related to acid balance in the body. The reported data shows that, for unwanted health events, 14 out of 31 pooled placebo participants reported such events, compared to 13, 9, and 17 out of 25–26 participants in the three twice-daily TRC101 dose groups, and 17 out of 28 in the once-daily TRC101 group. Regarding bicarbonate levels in the blood, the placebo group's average level changed by −0.2 mEq/L (a very small decrease) from the start of the study to day 15. By comparison, the reported average change in the TRC101 twice-daily groups was +3.2, +3.0, and +3.7 mEq/L respectively across the three dose levels, and +3.3 mEq/L for all TRC101 participants combined. The reported data also shows that more participants in the TRC101 groups had their bicarbonate level rise by 2, 3, or 4 units or more compared with the placebo group — for example, 18, 14, and 19 participants (across the three TRC101 dose groups) had a rise of at least 2 mEq/L, compared with 4 in the placebo group. Data for the once-daily TRC101 dose group was not reported for some of these secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02174731 · results posted 16 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,051 people in the roxadustat group and 1,055 people in the epoetin alfa group — a total of 2,106 participants. Both groups were already on dialysis for kidney disease. The trial was measuring changes in haemoglobin (Hb) levels — a measure of red blood cells in the blood — over time, comparing the two treatments. Around 982 and 990 participants in each group respectively completed the study. The reported data shows that the main thing being measured was how much participants' haemoglobin levels changed from their starting level, averaged across weeks 28 to 52 of the trial. In the roxadustat group, the reported average increase was 0.77 g/dL (grams per decilitre, a standard unit for measuring haemoglobin), while in the epoetin alfa group it was 0.68 g/dL. For a secondary measure looking at haemoglobin change up to week 36 (excluding people who received additional treatments), the reported figures were 0.88 g/dL for roxadustat and 0.74 g/dL for epoetin alfa. The reported data also shows that during weeks 28 to 52, participants in the roxadustat group spent about 79% of that time with haemoglobin at or above 10 g/dL, compared with 76% for epoetin alfa. Another secondary measure looked at LDL cholesterol (a type of fat in the blood) at week 24; the roxadustat group showed a reported average decrease of 0.38 millimoles per litre, while the epoetin alfa group showed a decrease of 0.05 millimoles per litre. Finally, among participants who had elevated inflammation markers at the start, the reported haemoglobin increase was 0.80 g/dL for roxadustat and 0.59 g/dL for epoetin alfa. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02065791 · results posted 20 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02065791) enrolled 4,401 people in total — 2,199 in the placebo group and 2,202 in the canagliflozin 100 mg group. The trial was measuring kidney and heart-related events in people taking either canagliflozin (a medicine used in type 2 diabetes) or a placebo (an inactive dummy pill). The main thing researchers tracked was a combined outcome that included a significant worsening of kidney function (specifically, a doubling of a blood marker called creatinine), reaching end-stage kidney disease (where the kidneys largely stop working), or dying from a kidney or heart-related cause. Several other heart and kidney outcomes were also tracked as secondary measures. The reported data shows the results as event rates — that is, roughly how many events occurred per 1,000 people over each year of the study. For the main combined kidney and heart outcome, the reported rate was 61.24 events per 1,000 participant-years in the placebo group, compared with 43.21 in the canagliflozin group. For the combined outcome of heart-related death and hospitalisation for heart failure, the reported figures were 45.44 (placebo) versus 31.47 (canagliflozin). For major adverse cardiac events — a combined measure of heart-related death, non-fatal heart attack, and non-fatal stroke — the reported rates were 48.67 (placebo) and 38.71 (canagliflozin). Hospitalisation for heart failure alone was reported at 25.33 (placebo) versus 15.65 (canagliflozin). The kidney-only combined outcome showed rates of 40.36 (placebo) versus 26.99 (canagliflozin), and heart-related death alone was reported as 24.38 (placebo) versus 19.01 (canagliflozin). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03177798 · results posted 29 October 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 11 people in total — 5 in one group and 6 in the other. It used a "crossover" design, meaning everyone received both the study drug (icatibant) and a dummy treatment (placebo) at different times, with a washout period in between. All 11 participants completed the trial. The study was looking at two things: how well the muscles' energy-producing units (called mitochondria) were working, and what happened to blood pressure during dialysis sessions. The reported data shows that mitochondrial function was measured by tracking how quickly a muscle energy molecule called phosphocreatine recovered after exercise — specifically, the time it took to reach about two-thirds of its peak level. According to the results reported on ClinicalTrials.gov, this recovery time was recorded as approximately 60.6 seconds when participants received icatibant, compared with approximately 62.7 seconds when they received the placebo. For blood pressure, the reported data shows systolic blood pressure (the "top number") at several points during dialysis: before dialysis it was around 123 mmHg (icatibant) versus 125 mmHg (placebo); during dialysis it was approximately 123 mmHg versus 122 mmHg; and after dialysis it was approximately 119 mmHg versus 124 mmHg. These numbers are simply the measurements recorded during the trial as submitted by the study sponsors. No conclusions about whether one set of results is better or worse than another should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02331680 · results posted 22 October 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02331680) involved 124 people across three groups: 40 received a 15mg daily dose of OPC-41061, 40 received a 30mg daily dose, and 44 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in daily urine volume and changes in the total amount of fluid removed by dialysis each week, comparing those numbers from the start of the trial to the end of the treatment period. The reported data shows that, for the main measure — change in daily urine volume — participants in the 15mg group produced on average 169.2 mL more urine per day compared to their starting point, and those in the 30mg group produced on average 111.8 mL more per day. By contrast, the placebo group produced on average 259.9 mL less urine per day compared to their starting point. For the secondary measure — change in the total volume of fluid removed by dialysis each week — the reported data shows the 15mg group had an average change of 485.9 mL, the 30mg group had an average change of 375.4 mL, and the placebo group had an average change of 1,099.5 mL. The data does not include further detail explaining the direction or context of the dialysis fluid figures beyond these numbers. It is also worth noting that not everyone completed the trial — 6 people in the 15mg group, 4 in the 30mg group, and 15 in the placebo group did not finish, though the reasons were not reported in this data summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02684435 · results posted 2 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 63 participants, all of whom completed the study with no drop-outs. All participants had chronic kidney disease (CKD) and had a suspicious or unclear kidney lesion (an abnormal area spotted on a scan) that needed further investigation. The trial was looking at whether a type of ultrasound scan using a contrast agent called Perflutren Lipid Microsphere — tiny microscopic bubbles injected into the bloodstream to make ultrasound images clearer — could help radiologists assess these kidney lesions. Specifically, the study measured how well this technique could identify which lesions were cancerous and which were not, compared to a confirmed reference standard. The reported data shows that, across all participants, 24 kidney lesions showed a change in how radiologists categorised them — for example, a change in size, calcification, or internal structure — when assessed using this imaging approach. For the primary measures of diagnostic accuracy, the reported data shows a sensitivity of 75% — meaning that, out of lesions that were confirmed as cancerous, 75% were correctly identified as such by the scan. The reported specificity was 71% — meaning that, out of lesions confirmed as non-cancerous, 71% were correctly identified as non-cancerous. These figures are described in the trial record as preliminary results. For the secondary outcome measures — which looked at accuracy figures generated from detailed numerical (quantitative) analysis of the scan data rather than a radiologist's visual judgement — the reported data shows that no results were submitted to ClinicalTrials.gov for either sensitivity or specificity. These data were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00567489 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 251 people with diabetes who were on peritoneal dialysis (a form of kidney treatment). Participants were split into two groups: 127 people received "non-glucose sparing prescriptions" (dialysis fluid containing more standard glucose) and 124 received "glucose sparing prescriptions" (dialysis fluid designed to reduce the amount of glucose absorbed from the fluid). The trial ran for six months and was mainly measuring changes in blood sugar control, tracked using a measure called HbA1c — a blood test that reflects average blood sugar levels over roughly three months. The reported data shows that for the primary outcome (change in HbA1c), the non-glucose sparing group's HbA1c rose by an average of 0.2% at the three-month mark and showed no change (0%) at six months, while the glucose sparing group's HbA1c fell by an average of 0.6% at both the three- and six-month marks. For the secondary outcomes, the reported data shows changes in diabetes medication use, cholesterol and fat levels in the blood, and other blood markers across both groups at three and six months — the numbers varied between groups across these measures. One severe low blood sugar event requiring medical help was reported in the non-glucose sparing group, and three such events were reported in the glucose sparing group. It is worth noting that 23 participants in the glucose sparing group did not complete the trial, compared with 7 in the other group, though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01427972 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people across 12 treatment sequence groups. It was a crossover study, meaning participants tried more than one treatment in sequence, with a washout (rest) period of at least 28 days in between. The trial was testing three different doses of an investigational medicine called LY2623091 (0.2 mg, 1.5 mg, and 10 mg) and comparing them to an existing medicine called eplerenone (50 mg). The main thing being measured was the change in proteinuria — the amount of protein leaking into a person's urine over 24 hours, which can be a sign of kidney stress — after 21 days on each treatment. The reported data shows the following changes in urine protein levels from the start of each treatment period to day 21: the 0.2 mg LY2623091 group showed a decrease of about 99 milligrams per 24 hours; the 1.5 mg group showed a smaller decrease of about 20 milligrams per 24 hours; the 10 mg group showed an increase of about 119 milligrams per 24 hours; and the eplerenone group showed an increase of about 274 milligrams per 24 hours. The reported data also shows changes in how the kidneys cleared potassium after an oral potassium drink — these changes were small across all groups. Blood concentration measurements of LY2623091 were also reported, showing that higher doses produced higher drug levels in the blood, as would generally be expected. One participant death was reported in the 1.5 mg LY2623091 group while on the study, though no further detail about the circumstances was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00567398 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 251 people with diabetes who were on peritoneal dialysis (a form of kidney replacement therapy). Participants were divided into two groups: 127 people received "non-glucose sparing prescriptions" (dialysis solutions that contain more glucose) and 124 received "glucose sparing prescriptions" (dialysis solutions designed to reduce the amount of glucose the body absorbs). The trial ran for six months and was primarily measuring changes in a blood sugar marker called HbA1c — a measure of average blood sugar levels over roughly two to three months. The reported data shows that, for the primary outcome, the non-glucose sparing group's HbA1c changed by +0.2% at three months and 0% at six months from their starting level. The glucose sparing group's HbA1c changed by -0.6% at both three and six months. For the secondary outcomes, the reported data shows changes in diabetes medication use, blood fats (such as cholesterol and triglycerides), and markers related to insulin. Regarding serious low blood sugar episodes requiring medical help, 1 event was recorded in the non-glucose sparing group and 3 events in the glucose sparing group over the whole study period. Changes in the various blood fat and protein measures were also recorded across both groups at three and six months, with the specific figures varying across the different measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02649946 · results posted 13 May 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 280 people in total — 142 in the covered stent group (who received a Covera Vascular Covered Stent after a balloon procedure called PTA) and 138 in the comparison group (who received PTA with an uncoated balloon only). The trial was looking at people who had a surgically created connection between an artery and vein (called an AV fistula) used for kidney dialysis. The main things being measured were: how many participants kept their treated blood vessel open without needing another procedure at the same site (called "target lesion primary patency"), and how many participants were free from serious unwanted events linked to their dialysis access. The reported data shows that, for the main "vessel staying open" measure, 105 out of 142 participants in the covered stent group met this outcome, compared with 55 out of 138 in the balloon-only group. For the serious unwanted events measure, 133 out of 142 participants in the covered stent group were free from such events, compared with 132 out of 138 in the balloon-only group. Looking at the 12-month follow-up specifically, the reported data shows 67 out of those assessed in the covered stent group still had their treated vessel open without re-treatment, compared with 23 out of those assessed in the balloon-only group. Additional measurements tracking the broader access circuit (not just the treated spot) were also reported at various time points up to 24 months, with the covered stent group generally showing higher numbers of participants maintaining patency at each time point, though the figures declined over time in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01567085 · results posted 3 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01567085) enrolled 80 participants, all of whom received at least one dose of the study drug, eculizumab. There was no comparison group — everyone in the trial received the same treatment. The trial was looking at what happened to kidney transplant recipients in the first 9 weeks after their transplant, specifically measuring a combined ("composite") outcome that included: a type of transplant rejection confirmed by tissue sample (acute antibody-mediated rejection, or AMR), loss of the transplanted kidney, death, or loss to follow-up. By the end of the study period, 60 participants had completed the trial and 20 had not. The reported data shows that out of 80 participants, 7 experienced what the trial defined as "treatment failure" — meaning they had at least one of those combined outcomes occur within the first 9 weeks. The remaining 73 did not meet that definition of treatment failure. Of the 7 who did, the data reported 3 cases of biopsy-confirmed AMR, 4 cases in another sub-category, and 1 case each in two further sub-categories (the exact breakdown labels were not separately named in the submitted data). The reported data also shows that at the 12-month mark, 3 participants developed a severe form of rejection (acute cellular rejection) that did not respond to standard treatments. For broader events tracked over 12 months, the reported data shows proportions for various complications: approximately 80% of participants experienced a clinically significant infection, around 30% experienced cytomegalovirus disease, and roughly 15–16% experienced BK virus disease or acute cellular rejection of any grade, among other figures. No cases of a rare lymph-system complication (post-transplant lymphoproliferative disease) were recorded in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02275923 · results posted 5 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02275923) enrolled 9 participants in a single "Diagnostic" group, with 7 completing the study and 2 not completing it. The trial was measuring two things during dialysis sessions: how much fluid was removed from participants, and how a body measurement called impedance (a way of passing a small electrical signal through the body to assess fluid levels in tissue just under the skin) changed from the start to the end of each session. The reported data shows that, on average across all participants and sessions, approximately 2,948 mL of fluid was removed during each dialysis session. The reported data also shows that the subcutaneous impedance measurement — that is, the electrical reading taken from just under the skin — changed by an average of 207 ohms from the beginning to the end of a dialysis session. No other outcome figures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02593149 · results posted 27 February 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02593149) involved people who were receiving haemodialysis (kidney dialysis) through a central venous catheter — a tube inserted into a large vein. The study was looking at whether positive blood cultures (blood tests that detect bacteria or other germs in the bloodstream) occurred at different rates between a treatment group and a control group. The trial had two phases: a run-in period, where around 340 treatment-group and 361 control-group participants started, and a main intervention period, where 942 treatment-group and 960 control-group participants started. The reported data shows that the main outcome measured was the number of positive blood cultures for every 1,000 days that participants had a central venous catheter in place. According to the results reported on ClinicalTrials.gov, the treatment group had a reported rate of 0.28 positive blood cultures per 1,000 catheter-days, while the control group had a reported rate of 0.75 positive blood cultures per 1,000 catheter-days. No secondary outcome measure data was included in the structured results provided, so those figures cannot be described here. It is also worth noting that the data does not report on reasons why some participants did not complete each phase of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02790606 · results posted 26 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 110 people who were receiving dialysis through an arteriovenous (AV) access graft — a surgically created connection used for dialysis. All participants received a device called the Covera™ Vascular Covered Stent, which was placed at a narrowed spot in the blood vessel connected to their dialysis access. The trial was measuring two main things: whether participants were free from serious unwanted events related to their dialysis access circuit, and whether the treated spot in the vessel stayed open without needing further treatment (called "target lesion primary patency"). Of the 110 who started, 75 completed the study and 35 did not. The reported data shows that, out of 110 participants, 106 were recorded as being free from serious adverse events (unexpected harmful events) directly related to their AV access circuit over the course of the study. For the question of whether the treated vessel site stayed open without needing another procedure, 71 out of the enrolled participants met that definition at the six-month mark — which was the main time point tested against a pre-set target of 40%. The reported data also shows how this "staying open" figure changed over time: at one month, 100 participants met the definition; dropping to 91 at three months, 46 at twelve months, 33 at eighteen months, and 25 at twenty-four months. A broader measure — tracking whether the entire dialysis access circuit (not just the treated spot) remained free from any repeat procedure or clotting — showed 96 participants meeting that definition at one month, falling to 72 at three months, 40 at six months, 14 at twelve months, 7 at eighteen months, and 4 at twenty-four months. The total number of repeat procedures to the access circuit across all participants grew over time, reaching 333 by twenty-four months. The number of participants recorded as having no device- or procedure-related adverse events in the access circuit at each time point was also reported, but the figures given show the count of those *without* such events: 105 at one month, 99 at three months, 96 at six months, 85 at twelve months, 77 at eighteen months, and 69 at twenty-four months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01652872 · results posted 8 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01652872) enrolled 756 participants in total — 377 in a group where the dose of a medicine called darbepoetin alfa was adjusted based on their haemoglobin (a measure of red blood cells in the blood), and 379 in a group that received a fixed dose. The trial was measuring whether participants needed red blood cell (RBC) transfusions — that is, receiving donated blood because their own blood cell levels were too low. Around 232 and 226 participants respectively completed the study in each group. The reported data shows that in the haemoglobin-based titration group, about 24.4% of participants received at least one red blood cell transfusion during the study period, compared with about 24.1% in the fixed dose group. On average, participants in the titration group received 0.71 units of transfused red blood cells, while those in the fixed dose group received 0.87 units. The reported data also shows that the average haemoglobin level achieved during treatment was 9.71 g/dL (grams per decilitre, a standard unit for measuring this) in the titration group and 9.41 g/dL in the fixed dose group. The average dose of the medicine given every four weeks was higher in the titration group (50.7 micrograms) compared with the fixed dose group (30.8 micrograms). The time-to-first-transfusion figures were also reported at four time points, but as the numbers are presented as statistical estimates rather than straightforward time measures, their plain meaning is not fully clear from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02002091 · results posted 14 September 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02002091) enrolled a total of 327 people with diabetes — 122 men and 205 women — who were screened for a range of diabetes-related complications. After an initial screening phase, 109 men and 191 women continued through to a one-year follow-up, all of whom completed that stage. The trial was measuring how many participants showed signs of six different complications: eye disease (diabetic retinopathy), nerve damage in the feet and legs (distal diabetic neuropathy), chronic kidney disease, high blood pressure, silent heart muscle problems (silent myocardial ischaemia — where reduced blood flow to the heart causes no obvious symptoms), and blocked arteries in the legs (lower extremity artery disease). The reported data shows the following numbers of participants identified with each condition. For eye disease, 9 men and 18 women were recorded as having diabetic retinopathy. For nerve damage, the numbers were notably higher — 42 men and 56 women. Chronic kidney disease was identified in 35 men and 43 women, while high blood pressure was recorded in 82 men and 136 women, making it the most commonly identified condition in both groups. For silent heart muscle problems, 11 men and 4 women were identified. Blocked leg arteries were found in 6 men and 12 women. No percentage breakdowns beyond these raw participant counts were provided in the submitted data. It is worth noting that the reported data shows participant counts only — the trial results as submitted do not include additional detail about how these numbers compare to what researchers expected to find, or other context about the participants' backgrounds. Any figures not listed above were not reported in the data provided to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01521494 · results posted 23 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 183 people across five groups. Participants were given one of four different daily doses of a medicine called PA21 (750 mg, 1,500 mg, 2,250 mg, or 3,000 mg per day), or a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in certain substances in the blood — specifically phosphorus, calcium, and a hormone called intact-PTH (a hormone that helps control calcium and phosphorus levels in the body). Not everyone who started the trial finished it: completion numbers ranged from 37 out of 39 in the lowest-dose group down to just 15 out of 36 in the highest-dose group, with 30 out of 37 completing in the placebo group. The reported data shows that for the main thing being measured — the change in blood phosphorus levels by the end of treatment — all four PA21 groups showed a reduction compared to where they started. The reported reductions were 1.84 mg/dL in the 750 mg group, 2.59 mg/dL in the 1,500 mg group, 3.17 mg/dL in the 2,250 mg group, and 3.78 mg/dL in the 3,000 mg group. By comparison, the placebo group showed a small increase of 0.14 mg/dL. For the secondary measurements, blood calcium levels showed small increases across all PA21 groups (ranging from +0.16 to +0.38 mg/dL) and a small decrease in the placebo group (−0.09 mg/dL). The reported data also shows that intact-PTH levels fell in all PA21 groups (ranging from −35.2 to −97.0 pg/mL) and rose slightly in the placebo group (+21.5 pg/mL). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00773513 · results posted 15 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 2,825 people in total — 1,413 in a group receiving existing erythropoiesis stimulating agents (ESAs, a type of medication used to boost red blood cell production) and 1,412 receiving a specific version called methoxy polyethylene glycol-epoetin beta (a longer-acting form of a similar medicine). The trial was tracking how long it took for serious events — specifically death from any cause, heart attack, or stroke — to occur, comparing the two groups over time. The reported data shows that for the main (primary) outcome — the time until a participant either died or had a non-fatal heart attack or stroke — both groups recorded a median (middle value) of 5.1 years. For the secondary outcome measuring time until death from any cause, the ESA group recorded 6.1 years and the methoxy polyethylene glycol-epoetin beta group recorded 5.9 years. For several other secondary outcomes — including time to heart attack, time to stroke, and time to a first non-fatal cardiovascular event — the data was recorded as "NA" (not available), meaning those specific figures were not reported in the submitted results. The reported data also shows that 0% of participants in either group developed a rare condition called antibody-mediated pure red cell aplasia (where the immune system attacks red blood cell production), though it is worth noting that far fewer participants completed the full study than started it, which may be relevant context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02160145 · results posted 8 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02160145) enrolled 1,519 people with a condition called ADPKD (a genetic kidney disease causing cysts to form on the kidneys) who were in the later stages of the disease. After an initial run-in phase to check suitability, 1,370 participants moved into the main part of the trial, where 683 were randomly assigned to receive tolvaptan and 687 received a placebo (a dummy pill). The trial was primarily measuring how quickly kidney function declined over time, using a standard calculation called eGFR — a measure of how well the kidneys are filtering the blood, expressed in units per year. The reported data shows that, for the primary outcome, kidney filtering function declined at an average rate of about 2.3 units per year in the tolvaptan group, compared with about 3.6 units per year in the placebo group. For a secondary measure — which looked at the rate of kidney function decline across the entire study period — the reported figures were approximately 3.2 units per year for the tolvaptan group and 4.2 units per year for the placebo group. The trial also measured changes in urine concentration (how concentrated the urine was). The reported data shows that urine concentration changed differently between the two groups across the study period, though interpreting what those numbers mean clinically is a matter for medical professionals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02238977 · results posted 17 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02238977) compared two medications — fluoxetine and bupropion — in people with depression. The study was measuring depression severity using a well-known rating tool called the Hamilton Depression Rating Scale (a 25-question interview conducted by a clinician, with scores ranging from 0 to 66, where higher scores indicate more severe depression). Only one person took part in the trial overall — one participant in the bupropion group and none in the fluoxetine group. The reported data shows that the single participant in the bupropion group had a Hamilton Depression Rating Scale score of 18 at the time of measurement. To put that number in context, the scale considers a score above 17 to be consistent with a diagnosis of major depression, and a score below 10 to indicate remission. No data was reported for the fluoxetine group, as no participants were enrolled in that group. Because only one person completed the study, the reported figures are extremely limited and do not allow for any meaningful comparison between the two groups. It is also worth noting that a clinical trial with only one participant is far too small to draw any conclusions about how a treatment performs — results from a single person cannot be applied more broadly. The reported data shows what was measured for that one individual only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02278562 · results posted 2 April 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total, split across three groups: 9 received Anakinra, 7 received Actos (pioglitazone), and 8 received a placebo. All 24 participants who started the study completed it, with no dropouts recorded. The trial was measuring how these treatments affected the way the body processes protein — specifically, how amino acids (the building blocks of protein) are used, and whether the body was building or breaking down protein overall and in the muscles. The reported data shows the following changes from the start of the study to its end. For the primary measure — a laboratory test of amino acid processing called the Leucine Disposal Rate — the Anakinra group showed a change of −0.011 mg/kg/min, the Actos group showed +0.005 mg/kg/min, and the placebo group showed +0.001 mg/kg/min. For whole-body protein balance (the difference between the body building and breaking down protein across the whole body), the reported changes were −0.184 mg/kg/min for Anakinra, −0.215 mg/kg/min for Actos, and +0.018 mg/kg/min for placebo. For the muscle-specific protein balance measure, the reported changes were −5.1 for Anakinra, +11.8 for Actos, and +134.1 for the placebo group (all in micrograms per 100 ml per minute). No information about whether these differences were statistically meaningful (i.e., unlikely to be due to chance) was included in the submitted data. It is worth noting that this was a small study with fewer than 10 people in each group, which limits how broadly any numbers can be interpreted. The reported data shows only the numerical changes measured; no conclusions about what those changes mean clinically were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00356265 · results posted 23 January 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people across three groups: 7 people with chronic kidney disease (CKD), 2 people with high blood pressure (hypertension), and 6 people without high blood pressure (normotensive). All 7 participants in the CKD group and both participants in the hypertension group completed the study, while 5 of the 6 normotensive participants completed it. The trial was measuring how blood vessels in the forearm responded to certain chemical signals — specifically, how a drug called L-NMMA (which blocks a natural substance that relaxes blood vessels) affected blood flow responses to a blood-vessel-narrowing agent called phenylephrine. This type of measurement is referred to as "vasoreactivity," meaning how strongly the blood vessels react. The reported data shows that in the primary outcome measuring forearm blood flow response to phenylephrine with L-NMMA, the CKD group had reported values of −0.48 and −0.31 (measured in units of millilitres per minute per unit of phenylephrine concentration), while the normotensive group had values of −0.22 and −0.16 in the same units. The negative numbers indicate a reduction in blood flow in response to the drug, with the CKD group showing larger negative values than the normotensive group. For the second primary outcome — which looked at vasoreactivity in relation to a naturally occurring substance called ADMA (a compound the body produces that can affect blood vessels) — no numerical results were reported in the data submitted to ClinicalTrials.gov. The hypertension group's figures were also not reported for the first primary outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00275509 · results posted 20 December 2017

According to the results reported on ClinicalTrials.gov, this trial compared two medications — Thymoglobulin and Daclizumab — used to prevent organ rejection in kidney transplant patients. A total of 56 people took part: 30 received Thymoglobulin and 26 received Daclizumab. All 30 participants in the Thymoglobulin group completed the study, while 25 of the 26 in the Daclizumab group completed it (one did not finish). The trial was measuring rates of kidney rejection within the first six months after transplant, looking at two types of rejection: one driven by immune cells (called cellular rejection) and one driven by antibodies produced by the immune system (called antibody-mediated rejection). The reported data shows the following numbers of participants who experienced rejection within six months. For cellular rejection (where the body's immune cells attack the transplanted kidney), 14 out of 30 participants in the Thymoglobulin group and 20 out of 25 participants in the Daclizumab group met the criteria. For antibody-mediated rejection (where the immune system produces proteins that attack the kidney), 17 out of 30 in the Thymoglobulin group and 16 out of 25 in the Daclizumab group were recorded. When looking at the combined figure — participants who experienced either or both types of rejection — the reported data shows 21 out of 30 in the Thymoglobulin group and 23 out of 25 in the Daclizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00752102 · results posted 8 December 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 44 participants in total — 22 in each group. One group received calcitriol and the other received paricalcitol, both of which are forms of vitamin D used in people with kidney disease. The trial was measuring how calcium built up in the coronary arteries (the blood vessels around the heart) over time in each group. This build-up was tracked using CT scans taken at the start of the trial and again at the end, with the amount of calcium measured using a scoring system called the Agatston score — essentially a number that reflects how much calcium deposit is present in those vessels. The reported data shows that, by the end of the trial, 19 out of 22 participants in the calcitriol group and 21 out of 22 in the paricalcitol group completed the study. The primary measurement was the change in the Agatston calcium score between the first and last CT scan. The reported data shows the average score change was 74.38 Agatston units in the calcitriol group and 106.32 Agatston units in the paricalcitol group. A higher number means a greater increase in calcium detected in the artery walls over the course of the trial. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so those figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02102204 · results posted 17 November 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 902 people who were given a medicine called etelcalcetide. Of those, 884 actually received the treatment and 598 completed the study, meaning 304 did not finish. The trial was measuring a range of things, including unwanted side effects (called adverse events), blood levels of a hormone that controls calcium in the body (parathyroid hormone, or PTH), levels of phosphorus and calcium in the blood, unusual shifts in laboratory test results, and whether the body developed an immune response (antibodies) to the medicine. The reported data shows that, out of the 884 people who received etelcalcetide, 768 experienced at least one adverse event of any kind. Of those, 436 had what were classified as treatment-related adverse events, and 287 experienced serious adverse events (meaning events that were life-threatening, required hospitalisation, or caused significant disability). For the blood-level measurements, the reported data shows that around 67–73% of participants had their PTH levels within a recommended target range at the three check-in points (6, 12, and 18 months). Roughly 37–40% had phosphorus levels at or below the normal upper limit at those same time points. The reported data also shows that between approximately 10% and 16% of participants had a calcium level recorded below a threshold of 7.5 mg/dL at some point during the study, with that proportion gradually increasing over time. A small number of participants — between 1 and 18, depending on which lab value was looked at — showed a notable worsening in certain laboratory results compared to where they started. Additionally, 111 participants developed antibodies that bound to etelcalcetide. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01155375 · results posted 6 November 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01155375) compared two types of iron treatment in children with chronic kidney disease — an intravenous iron medicine called ferumoxytol and standard oral iron tablets or liquid. A total of 14 children were enrolled: 8 in the ferumoxytol group and 6 in the oral iron group. All 14 received at least one dose of their assigned treatment. Thirteen children completed the study (7 in the ferumoxytol group and 6 in the oral iron group), with one participant in the ferumoxytol group not completing it. The reported data shows that, unfortunately, no outcome numbers are available for either the primary or secondary measures. The main thing being measured was the change in haemoglobin levels (a protein in red blood cells that carries oxygen) from the start of the study to week 5. A secondary measure looked at how the body processed ferumoxytol over time. Blood samples were collected from participants for both of these measures; however, according to the results reported on ClinicalTrials.gov, those samples were never sent for laboratory analysis. The sponsor noted that difficulty enrolling enough participants led to the studies being discontinued, and as a result, the datasets were too limited to produce any meaningful figures for either measure. The reported data shows that no conclusions about either treatment can be drawn from this trial, as the key measurements were not completed or reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01264679 · results posted 6 November 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01264679) enrolled 8 people in a single group who all received the study drug ferumoxytol, an iron-based treatment being investigated in people with chronic kidney disease. Of those 8 participants, 7 received at least one dose of the study drug, only 3 completed the trial, and 5 did not finish. The trial was designed to measure changes in haemoglobin (a protein in red blood cells that carries oxygen) and iron levels in the blood over several weeks. The reported data shows that no results are available for any of the outcome measures — the primary measure or either of the two secondary measures. Blood samples were collected from participants, but according to the submitted results, those samples were never sent for laboratory analysis. The sponsor discontinued the trial early due to significant difficulties recruiting enough participants, meaning the dataset was too limited to produce any meaningful numbers. As a result, no figures for changes in haemoglobin or iron levels were reported. Because the trial was stopped before it could be completed as planned, the reported data shows there are simply no outcome numbers to describe for this study. The absence of results means nothing can be concluded from this trial about the drug's performance on any of the measures it set out to examine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00717366 · results posted 8 September 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called MIRCERA in people who were already receiving treatment to support their red blood cell levels (measured as haemoglobin, or Hb — a protein in red blood cells that carries oxygen). The trial tested two different approaches for calculating the starting dose of MIRCERA: an "intermediate conversion factor" group (16 people) and a "high conversion factor" group (48 people). The main thing being measured was how much a person's average haemoglobin level changed after switching to MIRCERA, compared to where it started. The trial had a 20-week core period followed by a 52-week extension period, though not all participants who started went on to complete both stages. The reported data shows that at the start of the core study, the average haemoglobin level was 11.26 g/dL (grams per decilitre, a standard unit for measuring haemoglobin) in the intermediate group and 11.08 g/dL in the high group. By the evaluation period (weeks 17–21), the average change from baseline was −0.78 g/dL in the intermediate group and −0.15 g/dL in the high group, meaning both groups showed a slight decrease on average. For a secondary measure looking at how many participants stayed within 1 g/dL of their starting haemoglobin level, the reported data shows 7 out of the intermediate group and 27 out of the high group met this mark. When looking at whether participants' haemoglobin fell within a target range of 10–12 g/dL, 9 intermediate-group and 29 high-group participants were reported within that range, while 3 and 4 respectively were below it, and 0 and 3 were above it. One participant in the intermediate group and 2 in the high group received blood transfusions during the trial. The trial also measured the peak concentration of MIRCERA detected in the blood, which was reported as 37,700 pg/mL (picograms per millilitre) in the intermediate group and 66,100 pg/mL in the high group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01102140 · results posted 14 July 2017

According to the results reported on ClinicalTrials.gov, this trial involved 20 participants in total — 13 people were assigned to receive POMx (a pomegranate extract supplement) and 7 received a sugar pill (placebo). Of those, 10 in the POMx group and 5 in the placebo group completed the study, with 3 and 2 people respectively not finishing. The trial was measuring several markers in the blood related to oxidative stress (a process where harmful molecules can damage cells), collagen turnover (the body's process of building and breaking down scar-like tissue), and blood vessel function. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — this applies to the primary outcome (a marker called TBARS, which reflects oxidative stress in the blood) as well as all three secondary outcomes (F-8 Isoprostanes, Procollagen Types I and III, and Asymmetric Dimethylarginine). In other words, while the trial measured these markers, the actual figures for each group were not reported in the structured results data available on ClinicalTrials.gov. Because no measurement data was provided, it is not possible to describe what the numbers showed for either group in this trial. If you are interested in the full findings, you may wish to search for any published research articles linked to this study, or speak with a healthcare professional who can help you find that information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02054572 · results posted 14 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 6 participants, all of whom completed the study. All 6 received a single dose of a radioactively labelled form of the drug etelcalcetide (written as [¹⁴C]etelcalcetide), which allowed researchers to track exactly where the drug and its breakdown products travelled in the body and how they left it. The trial was primarily measuring how the drug moved through and was removed from the body — a type of investigation known as a "mass balance" or excretion study. The reported data shows that, in total, approximately 67% of the radioactive dose was accounted for across all the ways it left the body. Of that, around 35% was recovered through dialysis fluid, about 24% was found in faeces (bowel motions), roughly 0.75% appeared in urine, and smaller amounts were measured on the dialysis membrane and in other sampled material. Regarding how the radioactivity behaved in the blood, the reported data shows it reached its highest level in the bloodstream at around 10 minutes after the dose was given, with a peak concentration of 697 ng-eq/mL (a measure of how much drug-related material was present per millilitre of blood). The last detectable level in the blood was recorded at 164 days after dosing, and the time it took for the concentration in blood to fall by half — known as the "half-life" — was reported as approximately 35.9 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01414114 · results posted 11 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 37 adults who received a medicine called etelcalcetide. Thirty-two participants completed the study, while five did not. The trial was measuring changes in a hormone called PTH (parathyroid hormone) — a hormone that can become too high in people on kidney dialysis — as well as changes in calcium and phosphorus levels in the blood. Participants were also grouped by whether their starting PTH level was below or above 700 pg/mL (a unit used to measure hormone levels in the blood). The reported data shows that, across all participants, PTH levels fell by an average of 53.6% from their starting point during the measurement period. For those who started with lower PTH (at or below 700 pg/mL), the reported average reduction was 55.6%, and for those who started higher (above 700 pg/mL), it was 50.8%. The reported data also shows that 89% of all participants had their PTH reduce by at least 30% from their starting level — 95% in the lower-starting group and 80% in the higher-starting group. Regarding achieving a specific PTH target of 300 pg/mL or below, 56% of all participants reached this level overall, with 76% in the lower-starting group and 27% in the higher-starting group. In addition, blood calcium levels were reported to have changed by an average of −15.1% across all participants, and phosphorus levels changed by an average of −10.4%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01932970 · results posted 4 April 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01932970) enrolled 158 people who were given a medicine called etelcalcetide. Of those, 148 actually received the treatment and 140 completed the study. The trial was looking at what happened to participants' blood calcium levels and a hormone called parathyroid hormone (PTH — a substance the body makes to help control calcium) over a four-week treatment period. The reported data shows that for the main (primary) measure — the proportion of participants whose blood calcium dropped below a specific low threshold (7.5 mg/dL, a level considered notably low) — 0.7% of participants fell below that level during the four weeks. For a slightly higher calcium threshold (8.3 mg/dL), the reported figure was 15.6% of participants. Regarding parathyroid hormone, the data shows percent changes from participants' starting levels across the treatment period, with figures of −3.9%, −7.8%, and −10.9% reported at different time points (the specific time points were not detailed in the submitted data). The reported data also shows that 0.0% of participants experienced symptoms associated with low calcium during the treatment period. Regarding other pre-specified tracking, the reported data shows that 72 participants had some form of adverse event (an unintended or unwanted experience during the study), 17 had what were classed as serious adverse events, 2 stopped treatment due to an adverse event, 1 died, and 11 experienced adverse events considered possibly related to the study medicine — though further detail on the nature of these events was not included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01173848 · results posted 4 April 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total — 8 in the Vitamin D2 group and 11 in the Vitamin D3 group. The trial was measuring how many participants reached what was defined as a normal vitamin D level in the blood after taking one of the two forms of vitamin D supplement. Of the 19 who started, only 7 finished the trial — 4 from the Vitamin D2 group and 3 from the Vitamin D3 group, meaning a relatively large number of participants did not complete the study. The reported data shows that, for the primary outcome — the number of participants who reached normal vitamin D levels — 4 out of 8 people in the Vitamin D2 group and 4 out of 11 people in the Vitamin D3 group met that target. No secondary outcome data was reported in the structured results. It is worth noting that this was a very small trial, and the data as submitted does not include any further detail about why so many participants did not complete the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02392208 · results posted 30 March 2017

According to the results reported on ClinicalTrials.gov, 8 people took part in this trial, which looked at how the antibiotic telavancin behaves in the body when given to people on haemodialysis (a kidney-cleaning treatment). Each participant completed two periods of the study — one where they received telavancin before their haemodialysis session, and one where they received it after. The trial was measuring how the drug moved through the body, including how high the drug level in the blood got, how long it stayed in the body, and how quickly the body cleared it. The reported data shows that when telavancin was given before haemodialysis, the peak level of the drug in the blood was 33.1 micrograms per millilitre, compared to 38.1 micrograms per millilitre when given after. The time it took for half the drug to leave the body (known as "half-life") was reported as 13.4 hours before haemodialysis and 21.4 hours after — meaning the drug appeared to stay in the body longer when given after the session. The rate at which the body cleared the drug was reported as 11.8 mL/h/kg before haemodialysis and 6.1 mL/h/kg after, suggesting the body processed the drug more slowly after the session. The reported data also shows that the overall amount of drug the body was exposed to in the first 24 hours was 307 mcg·h/mL before haemodialysis and 465 mcg·h/mL after, with similar differences seen in the following 24-hour period (121 versus 220 mcg·h/mL). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01785849 · results posted 27 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 254 participants in each group — one group received a medicine called etelcalcetide, and the other received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in a hormone called PTH (parathyroid hormone), which is linked to kidney disease, as well as levels of calcium and phosphorus in the blood — all measured before dialysis sessions. By the end of the study, 220 participants in the etelcalcetide group and 193 in the placebo group had completed the trial. The reported data shows that for the main (primary) outcome — the proportion of participants whose PTH levels dropped by more than 30% from their starting level — 74.0% of participants in the etelcalcetide group reached this point, compared with 8.3% in the placebo group. For the secondary outcomes, the reported data shows that 49.6% of the etelcalcetide group had PTH levels at or below 300 pg/mL (a standard measurement unit for this hormone), versus 5.1% in the placebo group. Overall PTH levels changed by approximately −55% on average in the etelcalcetide group, compared with an increase of about 13% in the placebo group. Blood calcium levels changed by approximately −7.3% in the etelcalcetide group versus +1.2% in the placebo group. Phosphorus levels changed by about −7.7% in the etelcalcetide group versus −1.3% in the placebo group. The combined calcium-phosphorus measure changed by about −14.3% in the etelcalcetide group versus −0.2% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01788046 · results posted 27 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 260 people in the placebo group and 255 people in the etelcalcetide group — a total of 515 participants. The trial was measuring changes in a hormone called PTH (parathyroid hormone), which is linked to kidney disease and bone health, as well as changes in blood levels of calcium and phosphorus. These measurements were taken during a set period called the "efficacy assessment phase." Not everyone finished the trial: 56 people in the placebo group and 37 in the etelcalcetide group did not complete it. The reported data shows that for the main outcome — the proportion of participants whose PTH levels dropped by more than 30% from their starting level — 9.6% of the placebo group reached that threshold compared with 75.3% of the etelcalcetide group. For the secondary outcomes, the reported data shows that 4.6% of placebo participants versus 53.3% of etelcalcetide participants had average PTH levels at or below 300 pg/mL (a unit used to measure the hormone in blood). Looking at the average percentage change in PTH from the start of the trial, the placebo group's PTH rose by about 13.7%, while the etelcalcetide group's PTH fell by about 57.4%. Blood calcium levels changed by +0.58% in the placebo group and −6.69% in the etelcalcetide group. Phosphorus levels changed by −1.60% in the placebo group and −9.63% in the etelcalcetide group. The combined calcium-phosphorus measure changed by −1.06% in the placebo group and −15.84% in the etelcalcetide group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01785875 · results posted 27 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 891 participants across three groups: 384 people received a placebo, 384 received the study drug etelcalcetide in one set of related studies, and a further 123 received etelcalcetide in a separate but linked study. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events), whether any significant changes in laboratory test results occurred, and whether participants developed antibodies (immune proteins) against the study drug. It also looked at changes in a hormone called PTH — a hormone that affects calcium and bone — as a secondary measure. The reported data shows that adverse events of any kind were recorded in 354 out of 384 placebo participants, 337 out of 384 etelcalcetide participants in the first group, and 108 out of 123 in the second etelcalcetide group. Serious adverse events were recorded in 215, 141, and 36 participants in those same groups respectively. Regarding antibodies against the drug, 27 out of the combined etelcalcetide participants developed detectable antibodies, compared with 10 in the placebo group. For the secondary measures looking at PTH levels, the reported data shows that around 67–68% of etelcalcetide participants (combined) had their PTH level fall by more than 30% from their starting point during the assessment period, compared with roughly 81–83% of placebo participants. Separately, around 57% of etelcalcetide participants (combined) reached a PTH level at or below 300 pg/mL, compared with about 56% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00571194 · results posted 15 March 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom completed the study — no one dropped out. The trial involved a single treatment group who received pravastatin. The study was described as a single-dose pilot study, meaning it was a small, early-stage investigation designed to gather initial information rather than draw broad conclusions. The primary outcome being measured was pharmacokinetics — that is, how the body processes a drug over time, including how it is absorbed, distributed, and cleared from the body. However, the reported data shows that no numerical measurements were submitted to ClinicalTrials.gov for this primary outcome. Because no figures were provided in the results data, it is not possible to describe what the pharmacokinetic measurements found. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01977482 · results posted 14 February 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 216 people in total across six groups. One group received a control treatment (similar to a dummy or comparison treatment), while the other five groups received different daily doses of an investigational medicine called GSK1278863, ranging from 4 mg up to 12 mg. The trial was primarily measuring whether and how much the medicine changed participants' haemoglobin levels — haemoglobin being the protein in red blood cells that carries oxygen around the body — after four weeks. A number of additional measurements were also tracked over a longer period of up to 24 weeks. The reported data shows that after four weeks, the control group's haemoglobin level fell on average by 0.64 grams per decilitre (g/dL) from where it started, while the GSK1278863 groups showed smaller falls or slight rises: the 4 mg group changed by −0.24 g/dL, the 6 mg group by +0.08 g/dL, the 8 mg group by +0.42 g/dL, the 10 mg group by +0.64 g/dL, and the 12 mg group by +0.61 g/dL. At week 24, the reported haemoglobin readings across all groups were broadly similar, ranging from about 10.28 to 10.70 g/dL. The trial also tracked what share of time participants spent with haemoglobin within a target range of 10.0–11.5 g/dL during weeks 20 to 24; the reported figures ranged from about 37% to 75% of days depending on the group. No participant in any group reached the pre-set low haemoglobin stopping point of below 7.5 g/dL, according to the reported data. The reported data also shows that a hormone called erythropoietin (EPO) — which the body uses to signal red blood cell production — was measured throughout the trial. The largest average rise in EPO from the starting level was recorded in the control group (approximately 1,946 international units per litre), while the GSK1278863 groups showed much smaller rises, ranging from around 25 to 85 international units per litre depending on the dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00394953 · results posted 20 January 2017

According to the results reported on ClinicalTrials.gov, this trial involved 489 people with kidney disease who were on dialysis — 245 were given a medication called MIRCERA and 244 were given a medication called darbepoetin alfa. The trial compared the two treatments over roughly a year, looking at how well each one kept participants' haemoglobin (a measure of red blood cells in the blood) at a stable, adequate level. The main thing the researchers were measuring was whether participants could maintain their haemoglobin above a certain threshold without it dropping too much from where it started. The reported data shows that, for the primary (main) outcome, 64.1% of participants in the MIRCERA group met the haemoglobin stability target, compared with 40.4% in the darbepoetin alfa group. For one of the secondary (additional) outcomes, the average dose of medication needed changed over the course of the trial: the MIRCERA group saw an average increase in dose of about 6.8%, while the darbepoetin alfa group saw an average increase of about 58.8%. Blood pressure and pulse rate readings were also tracked at several points during the trial; the reported figures for both groups were broadly similar across those time points, though the specific numbers varied slightly. Regarding unwanted events during the trial, the reported data shows that 222 participants in the MIRCERA group and 217 in the darbepoetin alfa group experienced at least one adverse event (an unwanted or unexpected sign or symptom); serious adverse events were recorded in 99 and 94 participants respectively; and 14 deaths were reported in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00077766 · results posted 14 September 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 313 people in total — 157 in one group and 156 in the other. Participants were kidney disease patients on dialysis who were already being treated with a medicine to boost red blood cell production. The trial compared two treatments: an investigational drug called RO0503821, given once every two weeks, versus an existing medicine called darbepoetin, given once every one to two weeks. The main thing the trial was measuring was whether each person's haemoglobin level (a measure of red blood cells in the blood) stayed stable over time. By the end of the trial, 118 people in the RO0503821 group and 131 in the darbepoetin group had completed the study. The reported data shows that, on average, haemoglobin levels changed very slightly from the starting point to the later assessment period. In the RO0503821 group, the average change was +0.05 grams per decilitre (g/dL), and in the darbepoetin group it was −0.10 g/dL — both very close to zero, meaning levels were broadly similar to where they started. For a secondary measure looking at how many people kept their haemoglobin within 1 g/dL of their individual starting level, the reported data shows 91 out of 157 participants in the RO0503821 group and 102 out of 156 in the darbepoetin group met this target. The reported data also shows that 19 participants in the RO0503821 group and 16 in the darbepoetin group received red blood cell transfusions during the study period. Small changes in blood pressure and pulse rate were also measured and reported, with most figures hovering near zero change from the starting point in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00256750 · results posted 19 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00256750) enrolled 666 kidney transplant recipients across three groups: 221 people received cyclosporine (a standard anti-rejection medicine), 226 received a lower-intensity regimen of belatacept (called "Belatacept LI"), and 219 received a more-intensive belatacept regimen (called "Belatacept MI"). The trial tracked participants for up to 84 months (seven years). It was measuring three main things at 12 months after transplant: how many people were still alive with a working kidney, how many showed signs of declining kidney function, and how many experienced an episode of acute rejection (a process where the body attacks the transplanted organ). The reported data shows that, at 12 months, the percentage of participants still alive with a functioning kidney graft was 92.8% in the cyclosporine group, 96.5% in the Belatacept LI group, and 95.4% in the Belatacept MI group. When looking at kidney function — specifically, how many participants had low or declining kidney filtration rates — the reported figures were 77.9% in the cyclosporine group, 54.2% in the Belatacept LI group, and 55.0% in the Belatacept MI group meeting that measure. For acute rejection episodes by 12 months, the reported rates were 7.2% (cyclosporine), 17.3% (Belatacept LI), and 21.9% (Belatacept MI). A secondary measure of kidney filtration rate (mGFR, a direct test of how well the kidneys filter blood, measured in units of mL/min/1.73m²) was also reported at multiple time points, with the cyclosporine group averaging around 50–52, and the two belatacept groups averaging between 60 and 68 across the measured time points. Regarding serious unwanted medical events over the full 84-month follow-up, the reported data shows 107 participants in the cyclosporine group, 113 in the Belatacept LI group, and 117 in the Belatacept MI group experienced serious adverse events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01651000 · results posted 17 August 2016

According to the results reported on ClinicalTrials.gov, this trial involved 213 people in total — 72 who started on a sugar pill (placebo) and 141 who started on a capsule called CTAP101 30 μg. The trial was measuring changes in a hormone called iPTH (intact parathyroid hormone), which is a hormone produced by glands in the neck that helps control calcium levels in the body. The trial also looked at vitamin D levels in the blood. By the end of the study, 62 people in the sugar pill group and 113 in the CTAP101 group had completed the trial. The reported data shows that the main thing the trial was measuring was how many participants had their iPTH hormone level drop by 30% or more from where it started. According to the results reported on ClinicalTrials.gov, in the CTAP101 group, 46 out of 141 participants reached that 30% drop, compared with 6 out of 72 in the sugar pill group. A similar pattern was reported in a slightly narrower group of participants who followed the study rules most closely — again, 46 in the CTAP101 group and 5 in the sugar pill group reached that threshold. The reported data also shows that 113 out of 141 participants in the CTAP101 group reached what the researchers defined as a normal vitamin D level in the blood, compared with just 2 out of 72 in the sugar pill group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02282813 · results posted 17 August 2016

According to the results reported on ClinicalTrials.gov, this trial looked at a capsule treatment called CTAP101 in people with chronic kidney disease who also had a condition where a hormone called parathyroid hormone (PTH) — a substance the body makes to help control calcium and bone health — was too high. The trial was not randomised, meaning participants were not assigned to groups by chance. A total of 298 people started the trial across three groups: 103 people treated for 6 months, 153 people treated for 12 months, and 42 people who received a specific dose alongside additional treatment for 12 weeks. The main thing being measured was how many participants had their PTH level fall by 30% or more from where it started, by the end of treatment. A secondary measure looked at how many participants reached what the trial considered a normal level of vitamin D in the blood (25-hydroxyvitamin D at or above 30 ng/mL). The reported data shows that, for the primary measure — PTH dropping by at least 30% — 34 out of 103 participants in the 6-month group, 66 out of 153 in the 12-month group, and 30 out of 42 in the 12-week combination group met this threshold by the end of treatment. A secondary analysis looking at a slightly stricter group of participants (those who followed the treatment protocol most closely) reported very similar numbers: 34, 64, and 29 participants respectively. For the vitamin D measure, the reported data shows that by the end of treatment, 87 out of 103 participants in the 6-month group, 124 out of 153 in the 12-month group, and 38 out of 42 in the 12-week group had vitamin D levels at or above the target level. Again, the numbers were similar when looking only at the protocol-following group: 86, 120, and 37 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00605345 · results posted 5 August 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00605345) enrolled 71 people in total — 46 in a group receiving a treatment called CERA once a month, and 25 in a group receiving a treatment called darbepoetin alfa once every two weeks. Both treatments are injections used to support red blood cell production. The trial was measuring whether participants could maintain their haemoglobin (a protein in red blood cells that carries oxygen) within a stable target range over a set study period. Most participants completed the trial: 45 of 46 in the CERA group and 22 of 25 in the darbepoetin group. The reported data shows that for the main measure — the proportion of participants who kept their haemoglobin within the personalised target range during the 12-week assessment window — 64.3% of the CERA group and 57.1% of the darbepoetin group met this target. For the secondary measures, the average change in haemoglobin levels from the start to the end of the study period was very small: +0.08 g/dL in the CERA group and +0.05 g/dL in the darbepoetin group (g/dL is simply the unit used to measure haemoglobin in blood). The reported data also shows that 71.7% of the CERA group and 64.0% of the darbepoetin group kept their haemoglobin within the broader 10–12 g/dL range throughout the assessment period, with participants spending an average of 57.0 days (CERA) and 50.5 days (darbepoetin) within that range. Additional reported figures include how often doses needed to be adjusted — 73.9% of CERA participants and 56.0% of darbepoetin participants had a dose change during the dose-adjustment phase, while 33.3% and 20.8% respectively had a dose change during the later assessment phase. The reported data also shows that 1 person in the CERA group and 2 people in the darbepoetin group received a red blood cell transfusion during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01977573 · results posted 6 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 252 people in total across four groups. Two groups were made up of people who had never previously used a type of anaemia medicine called rhEPO ("rhEPO-naive") — 136 received the investigational drug GSK1278863 and 44 received a control (comparator) treatment. The other two groups were people already using rhEPO — 36 received GSK1278863 and 36 received the control. The trial was measuring whether GSK1278863 could bring haemoglobin levels (a measure of red blood cell health, reported in grams per decilitre, or g/dL) into a target range over 24 weeks, and also tracked a number of other markers in the blood. The reported data shows that at week 24, average haemoglobin levels across the groups were: for the rhEPO-naive GSK1278863 group, 10.20 g/dL (under the original dosing criteria) and 10.96 g/dL (under amended criteria); for the rhEPO-naive control group, 10.64 g/dL and 11.05 g/dL respectively. For the rhEPO-user GSK1278863 group, the figures were 10.03 g/dL and 10.42 g/dL, and for the rhEPO-user control group, 10.66 g/dL and 10.86 g/dL. In terms of how many individuals had haemoglobin within the target range at week 24: 78 participants in the rhEPO-naive GSK1278863 group, 20 in the rhEPO-naive control group, 22 in the rhEPO-user GSK1278863 group, and 19 in the rhEPO-user control group. No participant in any group met the pre-defined stopping rule, which would have required a haemoglobin reading below 7.5 g/dL. The reported data also shows changes in several other blood markers by week 24. A protein called hepcidin (involved in iron regulation) changed by approximately −19% in the rhEPO-naive GSK1278863 group, +7% in the rhEPO-naive control group, −10% in the rhEPO-user GSK1278863 group, and −17% in the rhEPO-user control group. The maximum recorded rise in erythropoietin (a hormone that stimulates red blood cell production) from starting levels was 7.27 units/litre for the rhEPO-naive GSK1278863 group and 27.05 units/litre for its control group, compared with 3.69 and 25.85 units/litre in the two rhEPO-user groups. Finally, a growth factor called VEGF showed a maximum percentage rise from starting levels of approximately 76% in the rhEPO-naive GSK1278863 group, 27% in the rhEPO-naive control group, 50% in the rhEPO-user GSK1278863 group, and 41% in the rhEPO-user control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01471041 · results posted 3 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people and looked at a device called the Venous Window Needle Guide (VWNG). This is a device designed to help nurses and technicians insert needles into an arteriovenous fistula — a surgically created connection between an artery and a vein in the arm that people on kidney dialysis need for their treatment. The trial measured whether the device could be used successfully to access the fistula and complete a dialysis session within three months. Of the 54 people who started, 47 completed the study and 7 did not. The reported data shows that, for the primary outcome — successful use of the device to access the fistula and complete dialysis within three months — 49 out of 54 participants had this recorded as a success. For the secondary outcome, which tracked how many participants experienced a complication during needle insertion using the device, the reported data shows that 14 out of 54 participants had at least one complication recorded. No further detail about the nature of those complications was included in the submitted results data. It is worth noting that this trial had only one group, meaning there was no comparison group receiving a different device or approach, so the numbers above reflect only the experience of people using the Venous Window Needle Guide. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01695746 · results posted 2 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 108 people, all of whom received a medicine called C.E.R.A. (a type of injection given to people with anaemia — a condition where the blood does not carry enough oxygen, often linked to kidney disease). The trial followed participants for up to 24 weeks and was measuring things like haemoglobin levels — a way of checking the amount of oxygen-carrying protein in the blood — as well as how the medicine was dosed and delivered. Of the 108 people who started, 96 completed the trial and 12 did not finish. The reported data shows that at the start of the trial (Week 0), participants had an average height of 163.15 centimetres and an average weight of 60.23 kilograms — these were recorded as baseline (starting point) measurements. For the main treatment-related findings, the reported data shows that 90.2% of participants reached a haemoglobin level within the target range of 10–12 grams per decilitre at least once during the study. On average, participants spent about 16.69 weeks within that target range over the course of the 24-week study. The average dose of C.E.R.A. given was 75.5 micrograms per month, and a total of 572 doses were delivered by injection under the skin (subcutaneous route), with no doses recorded as given through a vein (intravenous route). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00321919 · results posted 25 May 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 603 people with chronic heart failure and anaemia (low red blood cell levels), split into two groups: 301 received an earlier course of a medication called epoetin beta (a drug that stimulates red blood cell production), and 302 received the same medication but starting later. The trial was primarily measuring how long it took before participants experienced a serious heart-related event — such as a heart attack, stroke, severe heart failure, or certain irregular heart rhythms serious enough to require hospitalisation. The reported data shows that for the primary outcome — the median time (that is, the midpoint waiting time across the group) to a first cardiovascular event — the value was recorded as "not available" (NA) for both groups. The same was the case for the median time to death from cardiovascular causes and the median time to death from any cause, meaning those specific time-based figures were not reported in the submitted data. For deaths recorded during the study, the reported data shows that 31 participants in the early treatment group and 21 in the late treatment group died from any cause. Regarding deaths specifically linked to cardiovascular events, 8 participants in the early group and 6 in the late group were recorded. For worsening of heart failure symptoms (measured on a standard scale called the NYHA classification, which rates how much heart failure limits daily activity), 49 participants in the early treatment group and 42 in the late treatment group were reported to have experienced a worsening from their starting level. It is also worth noting that 75 participants in the early treatment group and 52 in the late treatment group did not complete the trial, though the reasons were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02224820 · results posted 23 May 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom completed the study with no dropouts. The trial was testing an intravenous treatment called IdeS in people awaiting a kidney transplant who had high levels of certain antibodies — called HLA antibodies — that can make it very difficult to find a compatible donor. The main thing researchers were measuring was whether the treatment could bring those antibody levels down to a point considered low enough to allow a transplant to go ahead (measured using a laboratory score called MFI, where a score below 1,100 was the target). The reported data shows that the average MFI score recorded was 372, which is below the 1,100 target the trial had set as its benchmark. For the secondary measurements, 76 adverse events (unexpected medical occurrences that were noted and recorded during the trial) were reported across all 8 participants. All 8 participants developed antibodies against the study drug itself over the 64-day follow-up period. The reported data also shows that the drug's level in the blood dropped by roughly half within approximately 5 hours (this is called the "half-life" — the time it takes for half the drug to leave the body). A measurement related to how the drug affected a type of protein in the blood (IgG) was recorded at 30 µg/mL, though the full context of what this figure represents was not described in detail in the reported data. It is worth noting that with only 8 participants, this was a very small study, and the results reflect a tightly controlled research setting. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00545571 · results posted 18 May 2016

According to the results reported on ClinicalTrials.gov, 120 people took part in this single-group trial, which looked at a medication called Mircera (also known as CERA) used to treat anaemia in people with kidney disease who were on dialysis. Of the 120 who started, 53 completed the study and 67 did not finish. The trial was conducted in Switzerland and Austria. The main thing the researchers were measuring was whether participants could keep their haemoglobin level — a measure of red blood cells in the blood — within a certain target range and close to their own personal starting level, over a period of roughly weeks 18 to 24 of treatment. The reported data shows that for the main (primary) measurement, 75.6% of participants had an average haemoglobin level that stayed within the target range and within 1 g/dL (a standard unit of measurement) of their own individual starting level during weeks 18 to 24. A secondary measurement found that, on average, haemoglobin levels changed by −0.4 g/dL from the starting point to that same period — meaning a very small average decrease. When looking only at whether participants stayed within the target range (without also accounting for their individual starting level), 48.4% met that measure. Over the longer follow-up period (weeks 18 to 52), participants spent an average of 130 days within the target range. The reported data also shows that during the longer follow-up period, 22% of all haemoglobin readings were above the target range and 38% were below it. On average, participants spent around 43 days above the target range and 48 days below it during that period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01633853 · results posted 15 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 204 people in total — 104 in a Vitamin D2 group and 100 in a 1,25(OH)2 Vitamin D3 group (an activated form of vitamin D). All participants completed the study with no drop-outs recorded. The trial was measuring blood levels of calcium, phosphorus, and a hormone called intact parathyroid hormone (iPTH, a hormone that helps regulate calcium and phosphorus in the body) after 24 months of follow-up. These were the primary things being tracked. The study also looked at blood vitamin D levels and how many participants developed a condition called secondary hyperparathyroidism (where the parathyroid gland becomes overactive). The reported data shows that at the 24-month mark, blood calcium levels were 2.31 mmol/L in the Vitamin D2 group and 2.33 mmol/L in the 1,25(OH)2 Vitamin D3 group. Blood phosphorus levels were 1.27 mmol/L and 1.25 mmol/L respectively. The iPTH hormone levels were reported as 96.5 pg/ml in the Vitamin D2 group and 108.1 pg/ml in the 1,25(OH)2 Vitamin D3 group. For the secondary outcomes, blood 25(OH) Vitamin D levels (a marker of vitamin D in the body) were 37.31 ng/ml in the Vitamin D2 group and 18.07 ng/ml in the 1,25(OH)2 Vitamin D3 group. The number of participants who developed secondary hyperparathyroidism was 14 in the Vitamin D2 group and 15 in the 1,25(OH)2 Vitamin D3 group. It is worth noting that the reported data does not include any statistical comparison figures (such as whether the differences between groups were considered meaningful by the researchers), so those results are not available here to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00975000 · results posted 29 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 57 participants in each group — one group received a medicine called cinacalcet, and the other received a placebo (a dummy treatment with no active ingredient). The trial was looking at people with a condition causing high calcium levels in the blood, and the main thing it set out to measure was how many participants had their corrected total blood calcium level fall below a certain threshold (10.2 mg/dL) during a set assessment period. Secondary measurements included changes in bone density, phosphorus levels, kidney function, and parathyroid hormone (a hormone that helps regulate calcium) levels. By the end of the study, 52 participants in each group had completed it. The reported data shows a notable difference in the primary outcome between the two groups. In the placebo group, 3.5% of participants had their blood calcium fall below the target level, compared with 78.9% of participants in the cinacalcet group. For the secondary measures, the reported data shows that blood calcium levels changed by −0.14 mg/dL in the placebo group and −1.53 mg/dL in the cinacalcet group from the starting point. Parathyroid hormone levels changed by −10.6 pg/mL in the placebo group and −127.9 pg/mL in the cinacalcet group. Phosphorus levels changed by +0.07 mg/dL (placebo) and +0.52 mg/dL (cinacalcet). Bone density at the hip changed by +1.05% (placebo) and +1.24% (cinacalcet) at 52 weeks. Kidney function (estimated using a standard calculation called eGFR) changed by +0.06 mL/min/1.73 m² in the placebo group and −0.37 mL/min/1.73 m² in the cinacalcet group — a small change in opposite directions, though what this means clinically is not described in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00064753 · results posted 26 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 4,110 people in total — 2,056 in a high-dose multivitamin group and 2,054 in a low-dose multivitamin group. The trial was measuring whether the dose of a multivitamin made a difference to serious health events in kidney transplant recipients, specifically looking at cardiovascular disease (problems with the heart and blood vessels), kidney graft failure, and death. The reported data shows that for the main outcome — a serious heart or blood vessel event such as a heart attack, stroke, or related condition — 269 participants in the high-dose group and 278 participants in the low-dose group experienced such an event. For the secondary outcomes, kidney graft failure was recorded in 181 participants in the high-dose group and 162 in the low-dose group. Deaths from any cause were reported in 217 (high-dose) and 214 (low-dose) participants. Heart attacks (fatal or non-fatal) occurred in 90 versus 86 participants, strokes (fatal or non-fatal) in 35 versus 32 participants, and resuscitated sudden death in 7 versus 9 participants, in the high-dose and low-dose groups respectively. The reported data shows broadly similar numbers across both groups for each outcome measured, though it is important to note that a full statistical analysis (which would assess whether any differences between the groups are meaningful or due to chance) was not included in the structured data submitted to ClinicalTrials.gov and therefore cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01222884 · results posted 24 July 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01222884) enrolled 351 participants in total — 234 in the Iron Isomaltoside 1000 group and 117 in the Iron Sucrose group. The trial was comparing two types of intravenous (injected into the vein) iron treatments used in people on dialysis. The main thing being measured was whether participants could keep their haemoglobin — a protein in red blood cells that carries oxygen — within a target range of 9.5 to 12.5 g/dL (grams per decilitre, a standard unit for measuring substances in blood) at the six-week mark. A secondary measurement looked at how much the haemoglobin level changed over the course of the trial. The reported data shows that at six weeks, 82.7% of participants in the Iron Isomaltoside 1000 group and 82.6% of participants in the Iron Sucrose group had haemoglobin levels within the target range. Regarding the change in haemoglobin levels, the reported data shows an average change of −0.07 g/dL in the Iron Isomaltoside 1000 group and −0.06 g/dL in the Iron Sucrose group — meaning haemoglobin levels remained very close to where they started in both groups. Of the 351 people who began the trial, 210 and 113 completed it in the respective groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01636466 · results posted 8 June 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01636466) was set up to compare two groups of kidney transplant recipients — one group converted to a medication called everolimus, and a control group that continued on their existing treatment. The trial was designed to measure whether new antibodies that target the donor organ (called donor-specific alloantibodies, or DSAs) developed over time, as well as whether participants needed to return to dialysis (a kidney filtering machine). Only one participant was enrolled in the everolimus conversion group, and no participants were enrolled in the control group. The reported data shows that no outcome measurements were recorded for either the primary measure (antibody levels against the donor organ) or the secondary measure (how many participants returned to dialysis). The single participant who was enrolled did not complete the study, and no numerical results were submitted for any of the outcome measures. In other words, the data fields for both outcomes are empty — no figures were reported. Because the trial enrolled only one participant and that person did not complete the study, the reported data does not provide any meaningful results to describe. No conclusions about the measures being studied can be drawn from what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01356966 · results posted 1 June 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total — 18 in the group that received tetrahydrobiopterin (a naturally occurring compound in the body) plus folate, and 14 in the group that received a placebo (inactive treatment) plus folate. By the end of the study, 16 people in the first group and 12 in the second group had completed the trial. The trial was measuring changes in two things over 12 weeks: nerve activity in the muscles at rest (called muscle sympathetic nerve activity, or MSNA — a measure of how active certain nerves controlling blood vessels are), and a measure of how stiff the body's arteries are (called the augmentation index, or AIx). The reported data shows that, for the primary outcome, the group taking tetrahydrobiopterin plus folate had an average decrease in resting nerve activity of 7.5 units (bursts per minute), while the placebo plus folate group had an average increase of 3.2 units. For the secondary outcomes relating to artery stiffness, the tetrahydrobiopterin plus folate group showed an average decrease of 5.8 percentage points in one measure of arterial stiffness and a decrease of 3.2 percentage points in a heart-rate-adjusted version of the same measure. The reported data shows the placebo plus folate group had average increases of 1.8 and 1.1 percentage points respectively in those same two measures. These numbers reflect what was recorded across this particular group of trial participants over the study period. No conclusions about what the treatment does or does not do should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01277510 · results posted 15 May 2015

According to the results reported on ClinicalTrials.gov, this trial involved 43 children — 21 who received a placebo (a dummy treatment) and 22 who received a medicine called cinacalcet. The trial was looking at whether cinacalcet could reduce levels of a hormone called iPTH (a hormone that controls calcium in the body) in children with a condition causing overactive parathyroid glands due to kidney disease. The trial had a double-blind phase (where neither the children nor the doctors knew who was receiving which treatment) lasting up to 30 weeks, followed by an open-label phase where everyone knew what was being given. It is worth noting that a large number of participants did not complete the double-blind phase — 13 out of 21 in the placebo group and 18 out of 22 in the cinacalcet group. The reported data shows that for the main thing being measured — the proportion of participants whose iPTH hormone level dropped by at least 30% from their starting level — 19.0% of those in the placebo group reached this target, compared with 54.5% of those in the cinacalcet group. For the secondary measurements, the reported data shows that around 23.8% of the placebo group and 27.3% of the cinacalcet group had their iPTH level fall to at or below a specific threshold (300 pg/mL). Blood calcium levels fell slightly in both groups (by about 1.0% in the placebo group and 4.6% in the cinacalcet group). Phosphorus (a mineral in the blood) rose by about 10.2% in the placebo group and 4.9% in the cinacalcet group. A combined calcium-phosphorus measure rose 8.0% in the placebo group and fell 2.0% in the cinacalcet group. The reported data also shows that children's growth rate (measured as centimetres grown per year) was approximately 3.1 cm/year in the placebo group and 3.3 cm/year in the cinacalcet group during the double-blind phase — these figures are as reported and no conclusions about the meaning of this difference are drawn here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01322347 · results posted 24 April 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01322347) enrolled 147 participants in each group — one group received a substance called Soluble Ferric Pyrophosphate (SFP) added to their dialysis fluid, and the other received standard dialysis fluid (placebo). The trial was primarily measuring changes in haemoglobin levels (a measure of red blood cells in the blood) over the treatment period. It also tracked iron-related measurements in the blood before and after dialysis sessions, as well as how many participants needed a blood transfusion during the study. The reported data shows that, for the main outcome, haemoglobin levels changed by an average of −0.5 grams per litre in the SFP group and −4.0 grams per litre in the placebo group — meaning both groups saw a decline on average, but the reported decline was smaller in the SFP group. For the iron-related blood measurements taken before and after dialysis sessions, the reported data shows larger increases from pre- to post-dialysis in the SFP group compared to the placebo group across several measures. Regarding blood transfusions, 6 participants in the SFP group and 12 in the placebo group were reported to have received a transfusion, with a total of 15 units of blood given in the SFP group compared to 29 units in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00501046 · results posted 2 March 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,015 people with chronic kidney disease — 508 received a treatment called AST-120 (an oral carbon-based capsule) and 507 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether AST-120 made a difference to three serious kidney-related events: needing to start dialysis, receiving a kidney transplant, or having a blood marker of kidney function (called creatinine) double in level. The trial also tracked side effects and looked at levels of certain vitamins in the blood over time. Notably, a large number of participants did not complete the study — 270 in the AST-120 group and 294 in the placebo group. The reported data shows that for the main combined endpoint (dialysis, transplant, or creatinine doubling), 172 out of 508 participants in the AST-120 group reached that milestone, compared with 183 out of 507 in the placebo group. When death was added as a fourth event to that combined endpoint, 204 participants in the AST-120 group and 217 in the placebo group met the criteria. Regarding side effects, the reported data shows that 438 people in the AST-120 group and 425 in the placebo group experienced a treatment-related adverse event (an unwanted health event that occurred during the trial), while serious adverse events were recorded in 156 people taking AST-120 and 178 taking placebo. Blood levels of vitamins A, B12, and vitamin D were also tracked at multiple time points across both groups, with the reported figures remaining broadly similar between the two groups throughout the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00500682 · results posted 2 March 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 510 people in the AST-120 group and 510 people in the placebo (inactive treatment) group — 1,020 participants in total. The trial was studying people with chronic kidney disease and was measuring whether AST-120 (an oral carbon-based capsule) had any impact on serious kidney-related events, compared to a placebo. Of those who started, 204 in the AST-120 group and 223 in the placebo group completed the study. The reported data shows that for the main (primary) outcome — which combined three serious kidney events: starting dialysis, receiving a kidney transplant, or having a key blood marker (creatinine, a waste product the kidneys filter) double in level — 178 participants in the AST-120 group and 177 participants in the placebo group met that combined measure. For a broader secondary outcome that also included death, 213 participants in the AST-120 group and 201 in the placebo group were recorded as reaching one of those four events. Regarding adverse events (unwanted health problems that occurred during the trial), 436 people in the AST-120 group and 448 people in the placebo group experienced at least one; and of those, 195 in the AST-120 group and 184 in the placebo group experienced a serious adverse event. The reported data also shows that levels of certain vitamins — Vitamin A, Vitamin B12, and 25-Hydroxyvitamin D (a form of Vitamin D) — were tracked across both groups at multiple time points during the study. Vitamin A levels across all time points ranged roughly from 1,142 to 1,199 ng/mL in the AST-120 group and 1,164 to 1,232 ng/mL in the placebo group. Vitamin B12 levels varied more widely — between approximately 494 and 688 pg/mL in the AST-120 group and 484 to 705 pg/mL in the placebo group. Vitamin D levels remained broadly similar across both groups throughout, ranging from about 21.4 to 22.1 ng/mL in the AST-120 group and 21.6 to 22.2 ng/mL in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01552954 · results posted 18 December 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 256 adults in total — 131 in a "conventional" low-salt diet education group and 125 in an "intensive" low-salt diet education group. Most participants finished the study (126 and 119 respectively). The trial was looking at whether more intensive education about reducing salt intake, alongside a blood pressure medication called olmesartan, would change the amount of protein leaking into participants' urine over 24 hours (a measure sometimes used to track kidney stress). Several other things were also tracked, including sodium (salt) in urine, blood pressure, and haemoglobin (a measure of red blood cells). The reported data shows that, for the main outcome — change in urinary protein between weeks 8 and 16 of the study — the conventional education group started at around 483 mg/day and was at 487 mg/day at week 16, a change of roughly −0.4 mg/day. The intensive education group started at around 570 mg/day and came down to 417 mg/day by week 16, a reported change of 154 mg/day. For the secondary outcomes, the reported data shows that sodium in urine dropped by about 9 units (mEq/day) in the conventional group and about 35 units in the intensive group between weeks 8 and 16. Systolic blood pressure (the top number) changed by about 0.6 mmHg in the conventional group and 1.7 mmHg in the intensive group; diastolic (the bottom number) changed by −0.7 mmHg and 0.5 mmHg respectively. Haemoglobin changes were small in both groups (around 0.46–0.62 g/dL). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01191255 · results posted 10 December 2014

According to the results reported on ClinicalTrials.gov, this trial involved people with kidney disease who needed help managing phosphorus levels in their blood. The trial had two main phases. In the first phase (the Safety Assessment Period, lasting 52 weeks), 149 people received an active control treatment and 292 received the study drug, KRX-0502 (ferric citrate). In the second phase (the Efficacy Assessment Period, lasting 4 weeks), 96 people were switched to a placebo (a dummy treatment with no active ingredient) and 96 continued on KRX-0502 (ferric citrate). The trial was primarily measuring changes in blood phosphorus levels, as well as a number of other blood markers related to iron stores and the use of additional medications. The reported data shows that, for the primary outcome — changes in blood phosphorus levels — the placebo group's average phosphorus level rose to 7.23 mg/dL by the end of the four-week second phase, compared to 5.44 mg/dL at the start of that phase. In the group that continued on KRX-0502 (ferric citrate), the average phosphorus level went from 5.12 mg/dL at the start of the second phase to 4.89 mg/dL at its end. For the secondary outcomes, the reported data shows that ferritin (an iron storage marker in the blood) averaged 631.87 ng/mL at the start of the first phase in the active control group and rose to 894.88 ng/mL in the KRX-0502 (ferric citrate) group by week 52. A measure of how well iron is being carried in the blood (called transferrin saturation) was reported at 29.7% for the active control group at the start and 39.2% for the KRX-0502 (ferric citrate) group at week 52. The reported data also shows that the average daily use of intravenous (IV, meaning delivered directly into a vein) iron was 3.83 mg/day in the active control group and 1.87 mg/day in the KRX-0502 (ferric citrate) group over 52 weeks. Average daily use of ESAs — medicines that stimulate the body to make red blood cells — was reported as 993.46 units/day in the active control group and 755.80 units/day in the KRX-0502 (ferric citrate) group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00416520 · results posted 23 October 2014

According to the results reported on ClinicalTrials.gov, this trial involved two main stages. In the first stage (the "open-label period"), 165 people received a treatment called MCI-196 and 171 people received a treatment called sevelamer. In the second stage (the "placebo-controlled withdrawal period"), participants who had been on MCI-196 were split into two groups: 50 continued on MCI-196 and 54 received a placebo (an inactive substitute with no medicine in it). This second stage was designed to measure what happened to phosphorus levels in the blood — a mineral that the kidneys normally help control — when some people stayed on MCI-196 and others switched to a placebo. The reported data shows the following numbers for the main (primary) outcome, which looked at how blood phosphorus levels changed between week 12 and week 16 of the study. Among those who continued on MCI-196, phosphorus levels fell by an average of 0.24 mg/dL. Among those who switched to placebo, phosphorus levels rose by an average of 1.27 mg/dL. For the secondary outcome — which looked at how phosphorus levels changed from the very start of the study to week 12 — the reported data shows that the MCI-196 group had an average decrease of 1.12 mg/dL, while the sevelamer group had an average decrease of 2.16 mg/dL. These numbers describe what was measured and recorded in the study under its specific conditions, and it is worth noting that not all participants completed each stage — for example, 60 people in the MCI-196 open-label group did not finish that period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00542386 · results posted 6 October 2014

According to the results reported on ClinicalTrials.gov, this trial tested a treatment called MCI-196 in people who needed help managing phosphorus and cholesterol levels — conditions commonly associated with kidney disease. Participants were split into five groups, each receiving a different daily dose of MCI-196 (3 g, 6 g, 9 g, 12 g, or 15 g), plus a placebo (dummy treatment) group. In total, 642 people started the trial — 104, 102, 99, 103, and 102 in each MCI-196 dose group respectively, and 132 in the placebo group. The trial ran for 12 weeks and measured two main things: changes in blood phosphorus levels and changes in LDL-cholesterol (often called "bad" cholesterol). The reported data shows that, compared to where participants started, blood phosphorus levels fell in all MCI-196 groups by the end of 12 weeks. The reductions ranged from −0.23 mg/dL in the lowest dose group up to −1.41 mg/dL in the highest dose group, while the placebo group showed a much smaller change of −0.12 mg/dL. For LDL-cholesterol, the reported data shows percentage reductions across all MCI-196 groups, ranging from about −16.7% at the lowest dose to around −29.4% at the 12 g dose, while the placebo group showed a small increase of approximately 2.8%. The secondary outcome measures — including changes in total cholesterol, HDL-cholesterol ("good" cholesterol), triglycerides (blood fats), and PTH (a hormone related to bone and mineral health) — were listed as outcomes but no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00542815 · results posted 23 September 2014

According to the results reported on ClinicalTrials.gov, this trial involved three groups of participants. A total of 432 people were in the main MCI-196 group (drawn from two earlier studies), 76 were in a smaller MCI-196 group (from one earlier study only), and 124 were in a comparison group receiving a treatment called sevelamer. The trial ran for 52 weeks and was primarily looking at changes in blood phosphorus levels — phosphorus is a mineral that can build up in the blood in people with kidney disease. A secondary measurement looked at changes in LDL cholesterol (often called "bad" cholesterol) in the blood. The reported data shows that, after 52 weeks, blood phosphorus levels fell in all three groups. In the main MCI-196 group, the average drop was 1.23 mg/dL; in the smaller MCI-196 group, the average drop was 1.47 mg/dL; and in the sevelamer group, the average drop was 2.26 mg/dL. For LDL cholesterol, the reported data shows percentage reductions across all groups: the main MCI-196 group saw an average fall of about 26%, the smaller MCI-196 group around 31%, and the sevelamer group around 29%. These are averages across the groups — individual results within each group would have varied. It is worth noting that not all participants completed the study: roughly 106 people left the main MCI-196 group before finishing, 32 left each of the other two groups, and the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01073462 · results posted 10 July 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 67 participants, all of whom received an intravenous (given through a drip) form of a medicine called paricalcitol. The trial was looking at how the medicine affected levels of a hormone called intact parathyroid hormone (iPTH) — a hormone that the body uses to help control calcium and phosphate in the blood. Kidney disease can cause these levels to go out of balance. Of the 67 people who started the trial, 26 completed it and 41 did not finish. The reported data shows that the main thing being measured was the percentage of participants whose iPTH levels fell within a target range set by kidney disease treatment guidelines. Across the different check-in points during the study, the reported figures ranged from around 28% to 43% of participants reaching that target range at any given time. The reported data also shows that at least 30% reduction in iPTH levels from the starting point was recorded in roughly 42% to 52% of participants at various time points, and about 45% of participants showed that reduction across at least two visits in a row. For two other things being tracked — high calcium levels in the blood and high phosphate levels — the reported figures for high calcium were very low (0% to 1.5% of participants at any given check-in), while high phosphate levels were recorded in 0% to around 31% of participants depending on the time point. The reported data also notes that the majority of participants (around 87%) were taking at least one other medicine during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00925587 · results posted 4 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 358 adults in total — 178 in a group receiving darbepoetin alfa every two weeks (Q2W) and 180 receiving it once a month (QM). Darbepoetin alfa is a medicine used to treat anaemia (low red blood cell levels) by stimulating the body to produce more red blood cells. The trial was primarily measuring whether the once-monthly dosing schedule produced a similar change in haemoglobin levels (haemoglobin is a protein in red blood cells that carries oxygen) compared with the every-two-weeks schedule. Of those who started, 142 in the Q2W group and 155 in the QM group completed the study. The reported data shows that, on average, haemoglobin levels rose by about 2.16 g/dL (grams per decilitre, a unit of measurement for haemoglobin in the blood) in the every-two-weeks group and about 1.97 g/dL in the once-monthly group, measured between weeks 29 and 33 of the trial. Both groups started with similar haemoglobin levels at the beginning of the trial (around 9.17 and 9.12 g/dL respectively). The reported data also shows that haemoglobin levels appeared to rise over the course of the trial in both groups, with figures recorded at weeks 3, 5, and 7. For a secondary measure — the proportion of participants whose haemoglobin reached at least 10.0 g/dL and rose by at least 1.0 g/dL from their starting level at any point — the reported figures were 97.9% in the every-two-weeks group and 98.1% in the once-monthly group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00364845 · results posted 21 May 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 28 received darbepoetin alfa (an injectable medicine used to stimulate red blood cell production) and 23 received a placebo (an inactive injection). The trial was measuring whether the treatment had any effect on how energetic or fatigued participants felt, as well as their haemoglobin levels (a measure of red blood cells in the blood) and overall quality of life. By the end of the study, 17 people in the darbepoetin alfa group and 12 in the placebo group had completed the trial. The reported data shows that the primary outcome — a self-rated energy and fatigue score from a health survey (where 0 is the worst and 100 is the best) — was 51.4 for the darbepoetin alfa group and 46.7 for the placebo group at week 24. For the secondary outcomes, 19 out of 28 participants in the darbepoetin alfa group reached a haemoglobin level of 110 g/L or above, compared with 7 out of 23 in the placebo group. The reported average haemoglobin during the evaluation period was 125.85 g/L in the darbepoetin alfa group and 104.50 g/L in the placebo group. A separate quality-of-life score (rated from −0.59 to 1.00, where higher means better) was reported as 0.763 for the darbepoetin alfa group and 0.712 for the placebo group at week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00994318 · results posted 7 May 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00994318) enrolled 626 people in total across three groups: 155 received an intravenous iron treatment called ferric carboxymaltose (FCM) with a higher iron storage target, 154 received FCM with a lower iron storage target, and 317 received standard oral iron tablets. The trial was measuring how long it took before participants either needed an additional or different anaemia (low red blood cell) treatment, or reached a certain low haemoglobin (the protein in red blood cells that carries oxygen) level — whichever came first. The reported data shows that, out of those who started the study, the number of participants who reached that combined endpoint was 36 in the FCM high-target group, 49 in the FCM low-target group, and 98 in the oral iron group. Conversely, the number who did not reach the endpoint was reported as 117, 103, and 210 in those same groups respectively. The trial used a statistical comparison method to look at differences between the three groups in sequence, though the detailed results of those comparisons (such as whether any differences were considered statistically meaningful) were not included in the structured data submitted to ClinicalTrials.gov. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00318812 · results posted 2 May 2014

According to the results reported on ClinicalTrials.gov, this trial involved 40 people in total — 18 in a group receiving heme iron (a form of iron taken by mouth, derived from animal blood) and 22 in a group receiving iron sucrose (an iron treatment given directly into a vein). All 40 participants completed the trial, with no drop-outs recorded. The trial was measuring iron levels in the blood over six months, looking at whether the two different ways of delivering iron led to different results on three blood markers. The reported data shows that after six months, the average haemoglobin level (a measure of red blood cell health, reported in grams per litre) was 117 g/L in the heme iron group and 113 g/L in the iron sucrose group. For ferritin — a protein that reflects how much iron is stored in the body, measured in micrograms per litre — the reported figures were 85.5 in the heme iron group and 244 in the iron sucrose group. For transferrin saturation — a measure of how much of the body's iron-carrying capacity is being used, reported as a percentage — both groups recorded the same figure of 21.5%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01324128 · results posted 1 April 2014

According to the results reported on ClinicalTrials.gov, this trial involved people on dialysis who had high levels of phosphorus in their blood — a common issue for dialysis patients. The trial ran in two stages. In Stage 1, 710 people were assigned to a treatment called PA21 and 349 were assigned to a comparison treatment called sevelamer carbonate. Of those, 515 and 293 respectively completed Stage 1. Stage 2 was a smaller follow-on phase involving 50 people on a standard dose of PA21 and 49 on a lower dose of PA21, with 42 and 46 completing that stage. The trial was measuring changes in the amount of phosphorus in participants' blood over time. The reported data shows the following numbers for the main (primary) outcome, which looked at how blood phosphorus levels changed between Week 24 and Week 27 in Stage 2: in the standard-dose PA21 group, the average change was +0.25 mg/dL (a very small rise), while in the lower-dose PA21 group the average change was +1.92 mg/dL (a larger rise). For the secondary outcome — which compared blood phosphorus changes from the start of the trial to Week 12 in Stage 1 — the reported data shows an average change of −2.19 mg/dL in the PA21 group and −2.45 mg/dL in the sevelamer carbonate group, meaning both groups showed a decrease in blood phosphorus levels over that period. It is worth noting that these are averages across groups of participants, and no information about other outcomes or unwanted effects was included in the data submitted to ClinicalTrials.gov for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00317239 · results posted 25 November 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 250 participants in total — 147 in the Ferric Carboxymaltose (FCM) group and 103 in the Ferrous Sulfate Tablets group. Of those, 134 and 84 participants respectively completed the study. The trial was measuring whether participants' haemoglobin levels — a protein in red blood cells that carries oxygen around the body — increased by a meaningful amount. Specifically, it tracked how many people in each group experienced a rise in haemoglobin of at least 1 gram per decilitre (a standard unit used to measure haemoglobin in the blood). The reported data shows that, among those in the Ferric Carboxymaltose group, 87 participants reached that haemoglobin increase of 1 g/dL or more. In the Ferrous Sulfate Tablets group, 35 participants reached the same threshold. No secondary outcome measure data appears to have been included in the submitted results, so further detail on other measurements was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01341782 · results posted 6 June 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 255 people on dialysis who had high levels of a hormone called parathyroid hormone (PTH) — a hormone that helps control calcium and phosphate in the body. Participants were split into two groups: 127 received a medicine called paricalcitol and 128 received a medicine called maxacalcitol. The trial was measuring how many people in each group brought their PTH levels into a target range (60–180 pg/mL, a standard unit of measurement) by the end of treatment, without also developing high calcium levels in their blood (a condition called hypercalcaemia). Around 112–114 people in each group completed the trial. The reported data shows that, for the main goal of the trial — reaching the PTH target range without high calcium — 27.7% of people in the paricalcitol group and 30.5% in the maxacalcitol group met this combined measure. For a separate secondary measure looking only at reaching the PTH target range (without the calcium condition attached), the figures were 31.5% and 32.8% respectively. The reported data also shows that 34.6% of the paricalcitol group and 39.1% of the maxacalcitol group achieved at least a 50% drop in PTH from their starting level without high calcium; when the calcium condition was removed, those figures rose to 44.9% and 50.8%. On average, participants in the paricalcitol group reached the 50% PTH-reduction target at roughly 3.9 out of the possible weekly visits, compared with 5.3 visits for the maxacalcitol group; for the target PTH range measure, the averages were 2.6 and 3.4 visits respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00883389 · results posted 21 August 2012

According to the results reported on ClinicalTrials.gov, this trial involved 26 participants who were all placed in a single group called the "Med-alert Bracelet Pilot Group." All 26 participants completed the study, with none dropping out. The trial was looking at whether participants found a med-alert device (a type of medical identification bracelet) useful for future healthcare, based on their answers to a survey questionnaire. The reported data shows that the primary outcome was measured using something called a Likert scale — a simple rating system where 0 meant "not useful," 1 meant "somewhat useful," and 2 meant "extremely useful." The average score reported across the group was 1, which corresponds to the "somewhat useful" response on that scale. No other outcome measures appear to have been reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01081665 · results posted 12 March 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT01081665) enrolled 237 people with chronic kidney disease, all of whom received the medication paricalcitol. The trial was observational in nature, meaning there was no comparison group — everyone received the same treatment. Of the 237 who started, 212 were included in the main analysis group, and 142 completed the full study period. The trial was primarily set up to track hospitalisations as a way of monitoring safety, and also measured several things related to how participants' bodies responded to the medication over up to 24 months. The reported data shows that, out of 237 participants, 85 were hospitalised at some point during the study, with a total of 59 separate hospitalisations recorded across the group (the remaining figures in that dataset were not clearly labelled in the submitted results, so they are not described here to avoid misrepresentation). For the main secondary outcome, the reported data shows that 78.3% of participants met the study's definition of a positive response — meaning their parathyroid hormone level (a hormone involved in controlling calcium in the blood) dropped by at least 40% from their starting level, and/or fell below a set threshold, on at least two consecutive measurements. The reported data also shows that 16 participants had high calcium levels in the blood at two consecutive measurements, 107 participants had high phosphorus levels at two consecutive measurements, and 81 participants had a combined calcium-phosphorus level above the defined threshold at two consecutive measurements. Regarding side effects and adverse events, the reported data shows that 196 participants experienced at least one adverse event of any kind, 170 experienced a serious adverse event (including deaths), and 94 experienced an event considered possibly related to the study drug. These numbers describe what was recorded and counted during the study period, not conclusions about cause. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00800683 · results posted 1 February 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 133 people in total — 65 in the placebo group and 68 in the linagliptin (BI 1356) group. Of those, 48 and 49 participants respectively completed the study. The trial was measuring changes in a blood marker called HbA1c, which reflects average blood sugar levels over roughly two to three months and is expressed as a percentage. The main question the trial was designed to answer was how much HbA1c changed after 12 weeks of treatment compared to where each participant started. The reported data shows that at the 12-week mark (the main outcome), participants in the placebo group had an average HbA1c change of −0.15 percentage points from their starting level, while those in the linagliptin group had an average change of −0.76 percentage points. The trial also tracked HbA1c changes at several later time points. The reported data shows that at weeks 18, 24, 30, 36, and 52, the placebo group's average changes hovered close to zero (ranging from +0.04 to +0.01 percentage points), while the linagliptin group's average changes ranged from −0.57 to −0.72 percentage points across those same time points. These numbers represent group averages that were mathematically adjusted to account for each participant's starting HbA1c level, kidney function, and prior diabetes medication use. The reported data shows these figures as adjusted means, meaning they reflect a statistical estimate rather than a simple average of raw measurements. No data was reported for any outcomes beyond what is described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01071070 · results posted 26 January 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT01071070) involved 216 participants split evenly into two groups of 108 people each (Group 1 and Group 2). The trial was measuring changes in a hormone called intact parathyroid hormone (iPTH) — a hormone involved in controlling calcium levels in the blood, which can become abnormal in people with kidney disease. Most participants finished the trial: 104 from Group 1 and 105 from Group 2. The reported data shows that for the main thing being measured — whether participants achieved two back-to-back drops of at least 30% in their iPTH levels from their starting point — 93 out of 108 people in Group 1 reached this outcome, compared with 57 out of 108 in Group 2. For the secondary measurements, the reported data shows that the average change in iPTH levels from the start to the end of the trial was a drop of about 343 units (pg/mL) in Group 1 and about 192 units in Group 2. When looking at whether participants ended the trial with iPTH levels in a specific target range (between 150 and 300 pg/mL), 19 people in Group 1 and 21 people in Group 2 fell within that range. Small changes in calcium levels, a combined calcium-phosphorus measure, and systolic blood pressure (the top number in a blood pressure reading) were also tracked, with modest reported changes across both groups in all three measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00239642 · results posted 10 January 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 145 participants in total, split across three groups receiving different doses of an iron supplement called Venofer (iron sucrose): a low dose (0.5 mg/kg), a medium dose (1.0 mg/kg), and a higher dose (2.0 mg/kg), with roughly 49 people starting in each group. The trial ran over 12 weeks and was primarily measuring how many participants experienced at least one unwanted side effect (called an adverse event). It also looked at whether participants met a set of blood-test targets related to iron levels, haemoglobin (a measure of red blood cell health), and stability of their existing anaemia medication dose. The reported data shows that for the primary measure — the number of people who had at least one adverse event — 27 out of 49 participants in the low-dose group, 25 out of 47 in the medium-dose group, and 26 out of 49 in the higher-dose group reported experiencing at least one such event. For the secondary measures, the reported data shows that meeting all three blood-test targets together (called "clinical success") was recorded in 44 people (about 95.7%) in the low-dose group, 40 people (about 88.9%) in the medium-dose group, and 33 people (about 82.5%) in the higher-dose group. Looking at individual targets, haemoglobin levels within the target range were recorded in 100% of the low-dose group, 95.6% of the medium-dose group, and 95.0% of the higher-dose group. Iron saturation within the target range was recorded in 44, 42, and 37 participants across the three groups respectively. It is worth noting that the trial was primarily designed to measure adverse events rather than to prove the treatment works, and the figures above simply reflect what was counted and recorded during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00090753 · results posted 5 January 2012

According to the results reported on ClinicalTrials.gov, this trial compared two treatments used to raise red blood cell levels in patients — a medicine called Methoxy Polyethylene Glycol-Epoetin Beta and a comparator ESA (ESA stands for erythropoiesis-stimulating agent, a type of medicine that encourages the body to make more red blood cells). A total of 748 people started in the Methoxy Polyethylene Glycol-Epoetin Beta group and 480 in the comparator group during the first treatment period. The trial tracked changes in haemoglobin — a protein in red blood cells that carries oxygen, measured in grams per decilitre (g/dL) — over the course of the study. The reported data shows that, on average, haemoglobin levels changed from where they started by minus 0.55 g/dL in the Methoxy Polyethylene Glycol-Epoetin Beta group and minus 0.38 g/dL in the comparator group by the last month of each participant's time in the study — meaning both groups showed a small average decrease from their starting levels. For the secondary outcome, the reported data shows that 94.3% of participants in the Methoxy Polyethylene Glycol-Epoetin Beta group and 93.3% in the comparator group experienced at least one adverse event (an adverse event is any unwanted health occurrence recorded during the study). No further breakdown of those adverse events was included in this section of the results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00497146 · results posted 23 December 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 115 people in the paricalcitol (the active treatment) group and 112 people in the placebo (inactive treatment) group, for a total of 227 participants. The trial was measuring changes in the heart over 48 weeks, specifically the size and function of the left ventricle — the main pumping chamber of the heart. The main thing being measured was called the Left Ventricular Mass Index (LVMI), which is essentially a way of gauging the mass or "weight" of that heart muscle relative to a person's height. Several measures of how well the heart relaxes between beats (called diastolic function) were also tracked as secondary measurements. The reported data shows that, for the primary measurement — change in LVMI over 48 weeks — the paricalcitol group showed an average change of +0.34 grams per metre²·⁷, while the placebo group showed an average change of −0.07 grams per metre²·⁷. For the secondary heart-relaxation measures, the reported data shows small numerical differences between the two groups across all measurements. Left atrial volume (the size of another heart chamber) changed by an average of −4.94 millilitres in the paricalcitol group and −0.92 millilitres in the placebo group. The other relaxation-related measurements showed only very small numerical differences between the two groups, as reported. It is worth noting that not all participants who started the trial completed it — 88 of 115 in the paricalcitol group and 91 of 112 in the placebo group finished the main treatment period. No information beyond these numbers was reported in the structured data provided to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00422513 · results posted 14 December 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 130 participants in each of two groups — one group received a medicine called Methoxy Polyethylene Glycol-epoetin Beta, and the other received a medicine called Epoetin Alfa. Both are treatments used to manage anaemia (low red blood cell levels) in people with kidney disease. The trial was designed to measure how long participants spent on anaemia treatment, and how their haemoglobin levels (a measure of red blood cells in the blood) changed over time. Only a small number of participants fully completed the study — 23 in the first group and 24 in the second. The reported data shows that the two main (primary) outcome measures — time spent on anaemia treatment and changes in haemoglobin levels — were not analysed, as the trial's sponsor noted that efficacy and pharmacoeconomic analyses were not performed. This means no numbers were reported for those key measures. For the secondary outcomes, 123 participants in the Methoxy Polyethylene Glycol-epoetin Beta group and 129 in the Epoetin Alfa group were assessed for adverse events (unwanted or unexpected health changes during the trial). The reported data also shows that notable abnormalities in laboratory test results were recorded across both groups, with various counts reported across different categories, though the specific category labels for each set of numbers were not included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00448708 · results posted 17 November 2011

According to the results reported on ClinicalTrials.gov, this trial compared two types of vascular grafts — a "Vascular Wrap and Graft" and a "Lifespan® ePTFE Vascular Graft" — used in blood vessel procedures. A total of 222 people took part (112 in the Vascular Wrap and Graft group and 110 in the Lifespan® ePTFE Vascular Graft group). The main thing the trial was measuring was how long each graft stayed open and functioning at the treated site before any further procedure was needed. It is important to note that the trial was stopped earlier than planned, which meant, as the researchers themselves acknowledged, there were not enough participants to draw firm conclusions about how the two grafts compared. The reported data shows that the average time before the graft at the treated site stopped functioning was 130 days for the Vascular Wrap and Graft group and 159 days for the Lifespan® ePTFE Vascular Graft group. For side effects (called adverse events), the reported data shows figures of 1,451 and 1,164 recorded events in the two groups respectively, though it is noted these figures reflect the total number of events rather than the number of individual people affected. When looking only at side effects occurring in at least 5% of participants, 17 people in the Vascular Wrap and Graft group and 21 people in the Lifespan® ePTFE Vascular Graft group experienced those events. No further breakdown of specific side effect types was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00968617 · results posted 11 November 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT00968617) enrolled 7 participants, all of whom received a treatment called MK2578. The trial was measuring changes in haemoglobin levels (a measure of red blood cells in the blood) over 4 weeks, as well as tracking a range of medical events such as heart-related problems, injection site reactions, high blood pressure, seizures, and whether the body developed antibodies (immune responses) against the treatment. Only 1 of the 7 participants completed the trial, while 6 did not complete it; the reasons for this were not detailed in the reported data. The reported data shows that, at the start of the study, the average haemoglobin level among participants was 9.3 grams per decilitre (g/dL), and the reported change from that starting point by Week 4 was 0.5 g/dL. Regarding the tracked medical events, the reported data shows that 0 participants experienced serious heart- or blood vessel-related events, and 0 participants had transfusion-related adverse experiences. One participant was reported to have had a reaction at the injection site, and one participant was reported to have experienced high blood pressure; no participants were reported to have had seizures or a condition called pure red cell aplasia (where the body stops producing red blood cells). For the measure of whether participants developed antibodies to MK2578, the result was listed as "not available" — meaning this data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00442702 · results posted 3 October 2011

According to the results reported on ClinicalTrials.gov, this trial compared two medicines — Mircera and Darbepoetin Alfa — used to treat anaemia (low red blood cell levels) in people with kidney disease. A total of 228 participants were enrolled at the start (114 in each group). The trial tracked levels of haemoglobin (a protein in red blood cells that carries oxygen) in the blood, first during a "titration period" where doses were adjusted, and then during an "evaluation period" where results were measured. The reported data shows that at the start of the evaluation period, average haemoglobin levels were similar in both groups — approximately 11.29 g/dL (grams per decilitre, a standard unit for measuring haemoglobin) in the Mircera group and 11.33 g/dL in the Darbepoetin Alfa group. The reported change in haemoglobin from the starting point to the evaluation period was +0.15 g/dL for the Mircera group and −0.03 g/dL for the Darbepoetin Alfa group. Regarding red blood cell transfusions (given when clinically needed), 9 participants in the Mircera group and 3 in the Darbepoetin Alfa group received at least one transfusion across the whole study. For reported adverse events (any unwanted medical occurrences noted during the study), 102 participants in the Mircera group and 88 in the Darbepoetin Alfa group experienced at least one adverse event; serious adverse events were reported in 41 Mircera participants and 23 Darbepoetin Alfa participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00636077 · results posted 1 July 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 people in total — three participants in each of four groups. The trial was comparing four different dialysis filters (called dialyzers) to see how increasing the flow rate of dialysis fluid affected how well each filter removed waste products from the blood. The four filters tested were: HD-C4 Big, HD-C4 Small, Optiflux F160NR, and Optiflux F200NR. Each participant used different filters across four weekly sessions. The trial measured two main things for three waste substances — urea, phosphorus, and beta-2 microglobulin: (1) "KoA," a technical figure describing how efficiently the filter is designed to remove a substance, and (2) actual measured clearance from whole blood during dialysis, recorded in millilitres per minute (mL/min). The reported data shows the following numbers across what appear to be three different dialysate flow rate settings tested during each week. For **urea clearance**, figures ranged from 270–279 mL/min at the lowest flow rate up to 313–340 mL/min at the highest, across the four filters. For **phosphorus clearance**, the reported range was 247–255 mL/min at the lowest flow rate up to 272–286 mL/min at the highest. For **beta-2 microglobulin clearance**, the reported numbers were notably lower and more variable, ranging from 65–119 mL/min at the lowest flow rate up to 75–121 mL/min at the highest. On the KoA efficiency figures, urea KoA values ranged from 748–844 at the lowest setting up to 761–922 at the highest; phosphorus KoA ranged from 334–504 up to 415–560; and beta-2 microglobulin KoA values were considerably lower, ranging from 27–65 down to 21–64 across settings and filters. It is worth noting that this was a very small trial with only three participants per group, and the reported data does not include any breakdown of results by individual or notation of which flow rate corresponds to which week's numbers. Any figures not described above were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00616902 · results posted 4 August 2010

According to the results reported on ClinicalTrials.gov, this trial (NCT00616902) enrolled 12 people in total — 6 received injections of a medicine called paricalcitol, and 6 received a placebo (a dummy injection with no active ingredient). The trial was designed to run for 48 weeks and was looking at whether paricalcitol had any effect on the heart in people with advanced chronic kidney disease who were on haemodialysis (a kidney-filtering treatment). Specifically, it planned to measure changes in the size and workload of the left side of the heart (using an MRI scan), as well as several measures of how well the heart relaxes between beats. The reported data shows that the study was ended early, before any participant reached the 24-week mark — meaning none of the 12 participants completed the trial. Because the trial was stopped early, the reported data shows that no results were available for the primary measure (heart muscle size on MRI) or for most of the secondary heart-function measures. The only outcome with numbers reported was a blood marker called Triiodothyronine (T3), which is a hormone that may influence heart function. The reported data shows that, from the start of the study to the point when participants left the trial (which varied between weeks 4 and 16), the average change in T3 levels was +0.005 nmol/L in the paricalcitol group and −0.152 nmol/L in the placebo group. No result figures were reported for any of the heart-related measurements, so those outcomes cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00095056 · results posted 23 July 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 91 people in total — 65 in the sitagliptin group and 26 in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial ran in two phases: the first 12 weeks (Phase A) and a longer follow-up period out to 54 weeks (Phase B). The main thing the trial was set up to measure was the safety and tolerability of sitagliptin — that is, tracking the number of participants who experienced any unwanted medical events (called "adverse experiences") during the study, including whether those events were considered serious or thought to be related to the study drug. The reported data shows that over the first 12 weeks, 41 out of 65 people in the sitagliptin group and 16 out of 26 in the placebo group had some kind of clinical adverse experience. Of those, 8 sitagliptin participants and 1 placebo participant had a serious clinical adverse experience, and 9 sitagliptin participants and 1 placebo participant had one the investigator considered possibly related to the drug. For laboratory-based adverse experiences (unusual results in blood or other tests), 9 sitagliptin and 5 placebo participants were affected; 1 sitagliptin participant had a serious lab adverse experience, and none in either group had a lab adverse experience considered drug-related. The reported data shows that over the full 54-week period, 50 out of 65 sitagliptin participants and 22 out of 26 placebo participants experienced a clinical adverse experience. Serious clinical adverse experiences were reported in 8 sitagliptin and 5 placebo participants, while 20 sitagliptin and 10 placebo participants had one considered possibly drug-related. Laboratory adverse experiences occurred in 15 sitagliptin and 8 placebo participants; 2 sitagliptin participants had a serious lab adverse experience, and none in either group had a drug-related lab adverse experience. Numbers for some sub-categories were not separately reported in the submitted data beyond what is described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00667576 · results posted 2 April 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people across five groups, all of whom were receiving a drug to help manage a hormone called parathyroid hormone (PTH) — a substance that the body produces in higher amounts when the kidneys are not working properly. Participants were assigned to one of four different dosing schedules of a drug called paricalcitol, or to a comparison drug called maxacalcitol. The main thing the trial was measuring was how many people in each group had their PTH blood level drop by at least half from where it started. Most participants finished the trial — between 27 and 30 people completed it in each group. The reported data shows that, for the primary measure (at least a 50% drop in PTH levels), the results varied across groups: 53.3% of participants in the paricalcitol 2 µg ±1 µg group, 41.9% in the paricalcitol 2 µg ±2 µg group, 38.7% in the paricalcitol 4 µg ±1 µg group, 56.7% in the paricalcitol 4 µg ±2 µg group, and 43.3% in the maxacalcitol group reached this point. For the secondary measures, the reported average reduction in PTH levels ranged from around 178 to 261 units (pg/mL) depending on the group. Roughly 32–37% of participants across all groups had their PTH level fall to 180 pg/mL or below. When looking at whether participants achieved that 50% drop on two or more separate occasions, the reported figures were notably higher — ranging from 90% to 100% across all groups. The trial also tracked two pre-specified measures related to mineral levels in the blood. The reported data shows that high calcium levels (hypercalcaemia, as defined by the trial) were recorded in 30.0% to 58.1% of participants depending on the group, and elevated phosphorus levels (hyperphosphataemia) were recorded in 9.7% to 19.4% of participants across groups. These are measurements that were tracked and reported; they are not presented here as conclusions about any drug's benefits or risks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00446459 · results posted 30 March 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people waiting for a kidney transplant who were given a medication called mycophenolate mofetil (MMF) on its own. The trial was measuring whether this medication could lower participants' levels of something called PRA — a measure of certain antibodies in the blood that can make it harder to find a compatible kidney donor. Twenty-two of the 34 participants completed the first eight months of the study, and four of those went on to complete the full twelve months. The reported data shows that at the eight-month mark — the trial's main goal — 9 out of 34 participants had their PRA level drop by 10% or more. For the secondary goals tracked over the study period, 4 participants experienced what the trial recorded as a significant infection, and 3 participants received a kidney transplant during the study period. When it came to transplants that took place with a "negative crossmatch" (meaning a lower risk of the body rejecting the new kidney), the reported number was 0 out of those who were transplanted. The reported data also shows that 0 participants had abnormally low white blood cell counts or antibody levels (IgG/IgM) — these were measurements the trial tracked as potential signs of a blood-related concern. It is worth noting that 18 of the 22 participants who entered the twelve-month phase did not complete it, and the reasons for this were not detailed in the data submitted. The data does not allow any conclusions to be drawn about why participants left the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00880750 · results posted 11 March 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 72 adults in total — 39 in one group and 33 in the other. It was a "crossover" study, meaning participants tried both forms of the same medicine (lanthanum carbonate) at different times: one group started with a granule form and then switched to a chewable tablet, while the other group did the opposite, with a washout break in between. The trial was mainly looking at how much phosphate (a mineral) participants passed out in their urine over three days, as a way of comparing how the two forms of the medicine performed. By the end of the trial, 56 of the 72 people who started had completed both treatment periods. The reported data shows that the main measurement — average urinary phosphate over three days — was 16.01 mmol for the granule form and 17.35 mmol for the chewable tablet form. On a single measurement day (day 4), the figures were 15.03 mmol for the granules and 17.01 mmol for the chewable tablet. The trial also measured how much of the medicine was absorbed into the bloodstream. The reported data shows that the overall amount of lanthanum carbonate detected in the blood over time (a measure called "area under the curve") was 14.2 ng\*h/ml for the granules and 10.3 ng\*h/ml for the chewable tablet. The peak level detected in the blood was 0.638 ng/ml for the granules and 0.504 ng/ml for the chewable tablet. The time it took to reach that peak level was reported as 4.00 hours for both forms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00922701 · results posted 17 June 2009

According to the results reported on ClinicalTrials.gov, this trial involved just 4 participants, all of whom completed the study — none dropped out. The trial was looking at a peritoneal dialysis solution, which is a fluid used in a type of kidney treatment where fluid is placed into the abdomen and then drained out. The main thing being measured was how much of that fluid could be recovered from the abdomen after it had been left in overnight (called a "long dwell"). The reported data shows that, on average, 2,167 millilitres of fluid was recovered from the abdomen at the end of the overnight exchange when using the peritoneal dialysis solution being tested. To put that in everyday terms, that is roughly equivalent to a little over two standard 1-litre water bottles. No secondary outcome measures were included in the submitted results data. It is also worth noting that with only 4 participants, this was a very small study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00428246 · results posted 3 June 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total, split evenly across three groups of 8 participants each. Most participants finished the study — 7 completed in Group 1, all 8 in Group 2, and 7 in Group 3. The trial was measuring whether a medicine called paricalcitol had any effect on markers of inflammation, blood vessel health, blood pressure, and kidney function in participants. The reported data shows results for one of the two primary outcome measures — a blood marker of inflammation called hsCRP (a protein that can rise when there is inflammation in the body). This was measured at the start of the study and again after 4 weeks. The reported change in hsCRP levels was 0.8 micrograms in Group 1, 0.5 micrograms in Group 2, and 1.5 micrograms in Group 3. For the second primary outcome (relating to blood vessel health) and both secondary outcomes (blood pressure and kidney function), no numerical results were reported in the data submitted to ClinicalTrials.gov — those figures are simply not available in the record. Because several outcomes have no reported numbers, only a partial picture of this trial's findings is available from the public record. The missing data was not reported rather than being absent due to any conclusion drawn here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.