A Phase 3 interventional study of MCI-196 and Placebo in Chronic Kidney Disease, Dialysis and Hyperphosphatemia, sponsored by Tanabe Pharma Corporation. Completed at 39 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
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, flexible dose titration, 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 245 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).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
Also known as: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
The Change in Serum Phosphorus From Week 12 to Week 16
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Time frame: 4 weeks (Week 12 to Week 16)
Change From Baseline in Serum Phosphorus
Time frame: 12 weeks (Week 0 to Week 12)
Change From Baseline in PTH
Time frame: 12 weeks
Change From Baseline in Calcium
Time frame: 12 weeks
Change From Baseline in Calcium x Phosphorus Ion Product
Time frame: 12 weeks
Change From Baseline in Total Cholesterol
Time frame: 12 weeks
Change From Baseline in LDL Cholesterol
Time frame: 12 weeks
Change From Baseline in HDL Cholesterol
Time frame: 12 weeks
Change From Baseline in VLDL Cholesterol
Time frame: 12 weeks
Change From Baseline in Triglyceride
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: 12 weeks (Week 0-12) and 4 weeks (Week 12-16)
| Milestone | MCI-196 | Placebo |
|---|---|---|
| Started | 245 | 0 |
| Completed | 169 | 0 |
| Not completed | 76 | 0 |
| Withdrew: Adverse event | 21 | 0 |
| Withdrew: Lack of efficacy | 13 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Physician decision | 5 | 0 |
| Withdrew: Protocol violation | 9 | 0 |
| Withdrew: Withdrawal by subject | 13 | 0 |
| Withdrew: Other reasons | 13 | 0 |
| Milestone | MCI-196 | Placebo |
|---|---|---|
| Started | 85 | 84 |
| Completed | 82 | 79 |
| Not completed | 3 | 5 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Other reason | 1 | 1 |
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
| mg / dL | MCI-196 (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|
| The Change in Serum Phosphorus From Week 12 to Week 16 | -0.04 ± 1.49 | 0.71 ± 1.71 |
| mg/dL | MCI-196 (Open-label Period) |
|---|---|
| Change From Baseline in Serum Phosphorus | -1.54 (-1.80 to -1.28) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 12 weeks (Week 0-12) and 4 weeks (Week 12 - 16). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCI-196 (Open-label Period) | — | 37/245 (15.1%) | 161/245 (65.7%) |
| MCI-196 (Double-blind Period) | — | 10/86 (11.6%) | 34/86 (39.5%) |
| Placebo (Double-blind Period) | — | 7/83 (8.4%) | 25/83 (30.1%) |
| Event | MCI-196 (Open-label Period) | MCI-196 (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|---|
| PneumoniaInfections and infestations | 3/245 | 2/86 | 0/83 |
| Fluid overloadMetabolism and nutrition disorders | 3/245 | 0/86 | 0/83 |
| PyrexiaGeneral disorders | 3/245 | 0/86 | 0/83 |
| AnaemiaBlood and lymphatic system disorders | 3/245 | 0/86 | 1/83 |
| HypertensionVascular disorders | 3/245 | 1/86 | 0/83 |
| HypotensionVascular disorders | 3/245 | 0/86 | 1/83 |
| Arteriovenous graft thrombosisInjury, poisoning and procedural complications | 3/245 | 0/86 | 0/83 |
| Arteriovenous graft site infectionInfections and infestations | 1/245 | 0/86 | 1/83 |
| Catheter site haemorrhageGeneral disorders | 1/245 | 0/86 | 1/83 |
| Chest painGeneral disorders | 1/245 | 0/86 | 1/83 |
| Event | MCI-196 (Open-label Period) | MCI-196 (Double-blind Period) | Placebo (Double-blind Period) |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 22/245 | 3/86 | 3/83 |
| NauseaGastrointestinal disorders | 21/245 | 4/86 | 0/83 |
| VomitingGastrointestinal disorders | 18/245 | 3/86 | 0/83 |
| ConstipationGastrointestinal disorders | 15/245 | 1/86 | 0/83 |
| DyspepsiaGastrointestinal disorders | 12/245 | 0/86 | 0/83 |
| Arteriovenous fistula site complicationInjury, poisoning and procedural complications | 11/245 | 1/86 | 1/83 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 11/245 | 0/86 | 1/83 |
| Back painMusculoskeletal and connective tissue disorders | 11/245 | 0/86 | 0/83 |
| HeadacheNervous system disorders | 10/245 | 1/86 | 2/83 |
| Upper respiratory tract infectionInfections and infestations | 9/245 | 0/86 | 0/83 |
| Age, Continuous(years) | MCI-196 |
|---|---|
| Mean | 55.8 ± 12.9 |
| Sex: Female, Male(Participants) | MCI-196 |
|---|---|
| Female | 99 |
| Male | 146 |
The record gives a start of Sep 2007, a primary completion of Sep 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 4 years 10 months after primary completion. A results delay was requested in May 2010.
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cholebine
Renal Insufficiency, Chronic →