A Phase 3 interventional study of MCI-196 and Another Phosphate binder (Sevelamer) in Chronic Kidney Disease, Dialysis and Hyperphosphatemia, sponsored by Tanabe Pharma Corporation. Completed at 115 sites in 15 countries. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 632 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
Drug: Another Phosphate binder (Sevelamer)
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Also known as: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
Current approved dosing recommendations for 12 weeks
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Change from Baseline to Week 52 (LOCF)
Time frame: 52 weeks (Baseline-52 weeks)
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Percent Change from Baseline to Week 52 (LOCF)
Time frame: 52 weeks (Baseline-52 weeks)
| Milestone | MCI-196 From E07 / E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study |
|---|---|---|---|
| Started | 432 | 76 | 124 |
| Completed | 326 | 44 | 92 |
| Not completed | 106 | 32 | 32 |
| Withdrew: Adverse event | 19 | 6 | 9 |
| Withdrew: Death | 10 | 7 | 3 |
| Withdrew: Lack of efficacy | 9 | 2 | 0 |
| Withdrew: Physician decision | 2 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 1 | 2 |
| Withdrew: Withdrawal by subject | 41 | 5 | 8 |
| Withdrew: Other reasons | 24 | 10 | 10 |
Change from Baseline to Week 52 (LOCF)
| mg / dL | MCI-196 From E07 / E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study |
|---|---|---|---|
| The Change in Serum Phosphorus for MCI-196 and Sevelamer | -1.23 ± 1.78 | -1.47 ± 1.68 | -2.26 ± 1.82 |
Percent Change from Baseline to Week 52 (LOCF)
| percentage change of LDL-cholesterol | MCI-196 From E07 / E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study |
|---|---|---|---|
| The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer | -26.22 ± 27.08 | -30.62 ± 20.12 | -28.66 ± 23.61 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCI-196 From E07/E08 Studies | — | 74/432 (17.1%) | 310/432 (71.8%) |
| MCI-196 From E07 Study | — | 31/76 (40.8%) | 75/76 (98.7%) |
| Sevelamer From E07 Study | — | 48/124 (38.7%) | 112/124 (90.3%) |
| Event | MCI-196 From E07/E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study |
|---|---|---|---|
| Atrial fibrillationCardiac disorders | 5/432 | 3/76 | 0/124 |
| PneumoniaInfections and infestations | 7/432 | 3/76 | 1/124 |
| AnaemiaBlood and lymphatic system disorders | 2/432 | 2/76 | 3/124 |
| Myocardial infarctionCardiac disorders | 2/432 | 2/76 | 1/124 |
| Arteriovenous fistula site complicationInjury, poisoning and procedural complications | 2/432 | 2/76 | 1/124 |
| Brachiocephalic vein stenosisVascular disorders | 2/432 | 2/76 | 1/124 |
| Circulatory collapseVascular disorders | 2/432 | 2/76 | 0/124 |
| Hypertensive crisisVascular disorders | 1/432 | 0/76 | 3/124 |
| Angina pectorisCardiac disorders | 0/432 | 0/76 | 2/124 |
| Abdominal painGastrointestinal disorders | 1/432 | 0/76 | 2/124 |
| Event | MCI-196 From E07/E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study |
|---|---|---|---|
| HypertensionVascular disorders | 55/432 | 23/76 | 39/124 |
| DiarrhoeaGastrointestinal disorders | 31/432 | 15/76 | 20/124 |
| VomitingGastrointestinal disorders | 37/432 | 15/76 | 13/124 |
| ConstipationGastrointestinal disorders | 32/432 | 14/76 | 14/124 |
| AnaemiaBlood and lymphatic system disorders | 34/432 | 13/76 | 22/124 |
| DyspepsiaGastrointestinal disorders | 40/432 | 13/76 | 9/124 |
| HypocalcaemiaMetabolism and nutrition disorders | 32/432 | 12/76 | 10/124 |
| Back painMusculoskeletal and connective tissue disorders | 14/432 | 10/76 | 6/124 |
| Abdominal painGastrointestinal disorders | 21/432 | 9/76 | 13/124 |
| Oedema peripheralGeneral disorders | 16/432 | 9/76 | 4/124 |
| Age, Customized(participants) | MCI-196 From E07 / E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study | Total |
|---|---|---|---|---|
| <65 years | 374 | 55 | 77 | 506 |
| >=65 years | 58 | 21 | 47 | 126 |
| Sex: Female, Male(Participants) | MCI-196 From E07 / E08 Studies | MCI-196 From E07 Study | Sevelamer From E07 Study | Total |
|---|---|---|---|---|
| Female | 203 | 25 | 53 | 281 |
| Male | 229 | 51 | 71 | 351 |
Showing the first 100 of 115 sites across 15 countries. Choose a country and city above to see the rest.
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 →