A Phase 3 interventional study of MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) and Placebo in Chronic Kidney Disease and Hyperphosphatemia, sponsored by Tanabe Pharma Corporation. Completed at 68 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 336 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Drug: Placebo
Drug: Another phosphate binder (Sevelamer)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Current approved dosing recommendations for 12 weeks
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.
Time frame: week16 minus week12
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)
ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.
Time frame: week12 minus week0
| Milestone | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) | MCI-196 (Placebo-controlled Withdrawal Period) | Placebo (Placebo-controlled Withdrawal Period) |
|---|---|---|---|---|
| Started | 165 | 171 | 0 | 0 |
| Completed | 105 | 139 | 0 | 0 |
| Not completed | 60 | 32 | 0 | 0 |
| Withdrew: Adverse event | 28 | 10 | 0 | 0 |
| Withdrew: Death | 2 | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 8 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 3 | 3 | 0 | 0 |
| Withdrew: Withdrawal by subject | 16 | 5 | 0 | 0 |
| Withdrew: Other reasons | 3 | 12 | 0 | 0 |
| Milestone | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) | MCI-196 (Placebo-controlled Withdrawal Period) | Placebo (Placebo-controlled Withdrawal Period) |
|---|---|---|---|---|
| Started | 0 | 0 | 50 | 54 |
| Completed | 0 | 0 | 49 | 49 |
| Not completed | 0 | 0 | 1 | 5 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 3 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 1 |
ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.
| mg / dL | MCI-196 (Placebo-controlled Withdrawal Period) | Placebo (Placebo-controlled Withdrawal Period) |
|---|---|---|
| Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) | -0.24 ± 1.46 | 1.27 ± 1.48 |
ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.
| mg / dL | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) |
|---|---|---|
| Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) | -1.12 ± 1.63 | -2.16 ± 1.55 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCI-196 (Open-label Period) | — | 26/162 (16%) | 126/162 (77.8%) |
| Sevelamer (Open-label Period) | — | 25/169 (14.8%) | 113/169 (66.9%) |
| MCI-196 (Placebo-Controlled Period) | — | 2/50 (4%) | 20/50 (40%) |
| Placebo (Placebo-Controlled Period) | — | 3/53 (5.7%) | 23/53 (43.4%) |
| Event | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) | MCI-196 (Placebo-Controlled Period) | Placebo (Placebo-Controlled Period) |
|---|---|---|---|---|
| BronchopneumoniaInfections and infestations | 0/162 | 1/169 | 1/50 | 0/53 |
| PneumoniaInfections and infestations | 0/162 | 0/169 | 1/50 | 0/53 |
| Respiratory distressRespiratory, thoracic and mediastinal disorders | 0/162 | 0/169 | 1/50 | 0/53 |
| AnaemiaBlood and lymphatic system disorders | 2/162 | 1/169 | 0/50 | 1/53 |
| Pyelonephritis acuteInfections and infestations | 1/162 | 0/169 | 0/50 | 1/53 |
| Arteriogram coronaryInvestigations | 0/162 | 2/169 | 0/50 | 1/53 |
| Dialysis device complicationInjury, poisoning and procedural complications | 0/162 | 0/169 | 0/50 | 1/53 |
| Myocardial infarctionCardiac disorders | 3/162 | 0/169 | 0/50 | 0/53 |
| Arteriovenous fistula thrombosisInjury, poisoning and procedural complications | 2/162 | 0/169 | 0/50 | 0/53 |
| Atrioventricular block completeCardiac disorders | 0/162 | 2/169 | 0/50 | 0/53 |
| Event | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) | MCI-196 (Placebo-Controlled Period) | Placebo (Placebo-Controlled Period) |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 27/162 | 9/169 | 1/50 | 0/53 |
| DiarrhoeaGastrointestinal disorders | 21/162 | 16/169 | 2/50 | 1/53 |
| NauseaGastrointestinal disorders | 15/162 | 12/169 | 0/50 | 1/53 |
| ConstipationGastrointestinal disorders | 13/162 | 11/169 | 2/50 | 0/53 |
| DyspepsiaGastrointestinal disorders | 13/162 | 6/169 | 0/50 | 1/53 |
| HypertensionVascular disorders | 12/162 | 12/169 | 1/50 | 1/53 |
| Abdominal pain upperGastrointestinal disorders | 10/162 | 8/169 | 1/50 | 0/53 |
| Haemodialysis-induced symptomInjury, poisoning and procedural complications | 6/162 | 9/169 | 3/50 | 0/53 |
| Abdominal painGastrointestinal disorders | 8/162 | 4/169 | 0/50 | 0/53 |
| NasopharyngitisInfections and infestations | 8/162 | 7/169 | 0/50 | 0/53 |
| Age, Continuous(years) | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) | Total |
|---|---|---|---|
| Mean | 56.4 ± 14.7 | 59.5 ± 13.8 | 58.0 ± 14.3 |
| Sex: Female, Male(Participants) | MCI-196 (Open-label Period) | Sevelamer (Open-label Period) | Total |
|---|---|---|---|
| Female | 54 | 72 | 126 |
| Male | 108 | 97 | 205 |
The record gives a start of Jun 2007, a primary completion of Nov 2009 and a completion of Nov 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2014, 4 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholebine
Renal Insufficiency, Chronic →