A Phase 3 interventional study of MCI-196 in Chronic Kidney Disease, Dialysis and Hyperphosphatemia, sponsored by Tanabe Pharma Corporation. Completed at 21 sites in 2 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
The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.
The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 116 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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Also known as: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
Number of Adverse Events (AE)
Time frame: 52 weeks
The Change in Serum Phosphorus From Baseline to Week 52
Time frame: 52 weeks
| Milestone | MCI-196 |
|---|---|
| Started | 116 |
| Completed | 61 |
| Not completed | 55 |
| Withdrew: Adverse event | 19 |
| Withdrew: Death | 6 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Physician decision | 5 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Other reasons | 10 |
| participants | MCI-196 |
|---|---|
| At least 1 treatment-emergent AE | 109 |
| At least 1 drug-related treatment-emergent AE | 50 |
| At least 1 treatment-emergent serious AE | 63 |
| mg/dL | MCI-196 |
|---|---|
| The Change in Serum Phosphorus From Baseline to Week 52 | -1.18 ± 2.05 |
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCI-196 | — | 63/116 (54.3%) | 106/116 (91.4%) |
| Event | MCI-196 |
|---|---|
| Coronary artery diseaseCardiac disorders | 9/116 |
| PneumoniaInfections and infestations | 7/116 |
| Cardiac failure congestiveCardiac disorders | 7/116 |
| SepsisInfections and infestations | 6/116 |
| HyperkalaemiaMetabolism and nutrition disorders | 6/116 |
| Urinary tract infectionInfections and infestations | 5/116 |
| Atrial fibrillationCardiac disorders | 5/116 |
| Fluid overloadMetabolism and nutrition disorders | 5/116 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/116 |
| Hypertensive crisisVascular disorders | 3/116 |
| Event | MCI-196 |
|---|---|
| NauseaGastrointestinal disorders | 26/116 |
| VomitingGastrointestinal disorders | 24/116 |
| DiarrhoeaGastrointestinal disorders | 23/116 |
| Decreased appetiteMetabolism and nutrition disorders | 14/116 |
| Haemodialysis-induced symptomInjury, poisoning and procedural complications | 13/116 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 13/116 |
| ConstipationGastrointestinal disorders | 11/116 |
| Arteriovenous fistula site complicationInjury, poisoning and procedural complications | 11/116 |
| CoughRespiratory, thoracic and mediastinal disorders | 11/116 |
| NasopharyngitisInfections and infestations | 11/116 |
| Age, Continuous(years) | MCI-196 |
|---|---|
| Mean | 57.3 ± 13.8 |
| Sex: Female, Male(Participants) | MCI-196 |
|---|---|
| Female | 40 |
| Male | 76 |
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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Renal Insufficiency, Chronic →