Trial 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
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.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Chronic Kidney Disease Trial, Terminated
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are 18 years of age or older at the time of screening
- You have been diagnosed with IgA nephropathy (a kidney disease), confirmed by a biopsy taken within the last 8 years
- Your medical records show a significant level of protein in your urine within the last 6 months, or a urine test at screening shows a raised protein level
- Two urine measurements taken at the start of the trial both show a high level of protein
- Your kidneys are working at a reasonable level, based on a blood test measuring kidney function (confirm with trial site for exact values)
Who may not be able to join:
- You have taken certain immune-suppressing medications (such as azathioprine, cyclophosphamide, or eculizumab) in the last 8 weeks for your kidney condition
- You have taken steroid tablets or injections (such as prednisone) in the last 8 weeks
- Your blood pressure is not well controlled and remains very high even while taking two or more blood pressure medications
- You are pregnant, breastfeeding, planning to become pregnant, or a male planning to father a child during the trial or within 12 weeks after the last dose of the study drug
- You have Type 1 diabetes, poorly controlled diabetes, lupus, a related condition called IgA vasculitis, or another kidney disease
- You have a serious illness or condition that could affect the trial results or may be life-threatening within the next 2 years
- You have previously had a kidney transplant
- You have a known allergy to any ingredient in the study drug
- Your kidney function has declined very rapidly in the months before screening (confirm with trial site for exact values)
- Your routine blood or urine lab results show significant abnormalities (confirm with trial site)
- You have HIV, a weakened immune system, active hepatitis C, or hepatitis B infection (some people with past hepatitis exposure may still be eligible — confirm with trial site)
- You have been diagnosed with cancer, unless it was a skin cancer that was fully treated, a fully cured localised cancer, or you have been cancer-free for 5 or more years
- You have taken part in another clinical drug or device trial within the last 30 days (or longer, depending on the previous drug — confirm with trial site)
- You have recently started or changed the dose of a type of diabetes/kidney medication called an SGLT2 inhibitor during the screening period (a stable dose taken for at least 8 weeks before screening may be acceptable)
- You have taken a medication called Tarpeyo (budesonide) or another approved IgA nephropathy treatment within the last 6 months, or are taking it during the screening period
- You have taken a medication called Kerendia (finerenone) within the last 6 months, or are taking it during the screening period
- You have recently started a medication called Filspari (sparsentan) within the last 3 months (a stable dose started at least 3 months before screening may be acceptable — confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percent Change in 24-hour UPE in g/Day Compared to Baseline
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.