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 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40576086) ↗
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, Completed
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 a man or woman aged 18 or older
- You are on haemodialysis or peritoneal dialysis (kidney filtering treatments) and your condition is stable
- Your phosphate levels are being managed and are stable
- You are following a set diet to control your phosphorus intake
- If you are a woman who could become pregnant, you have a negative pregnancy blood test before joining
- If you are a man, you must agree to use appropriate contraception during the trial
Who may not be able to join:
- You have a serious medical condition that could put you at risk, affect your safety, or interfere with the study (the trial doctor will decide this)
- Your Body Mass Index (BMI — a measure of body weight relative to height) is very low (16 or below) or very high (40 or above)
- You currently have or have had significant problems with how your digestive system moves food through your body
- You have tested positive for HIV 1 or HIV 2
- You have had problems with alcohol or drug misuse within the past year
- You have a seizure disorder (such as epilepsy)
- You have a history of allergies to drugs or other substances
- You are using a temporary catheter to access your blood for dialysis
- You have taken part in a clinical trial using an experimental medication in the last 30 days, or an experimental biological treatment in the last 90 days
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
Principal Investigator: Professor, Information at Mitsubishi Pharma Europe
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
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.