CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 336 enrolled
Drug / intervention
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) +2 moredrug
Likely dose
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) 3gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00416520
NCT00416520Phase 3Completed
CompareCT.gov

A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Tanabe Pharma Corporation·interventional·Posted Dec 28, 2006·Updated Jan 8, 2026

In Brief

A Phase 3 clinical trial evaluating MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®), Placebo, and 1 other intervention for Chronic Kidney Disease and Hyperphosphatemia. Completed, enrolled 336 participants across 68 sites in 11 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Hyperphosphatemia
CountriesAustralia, Austria, Czechia, France, Germany, Hungary, Italy, Poland, South Africa, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2006
Enrollment StartJun 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.5 years ago

Interventions

MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)drug

3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind

Placebodrug

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Another phosphate binder (Sevelamer)drug

Current approved dosing recommendations for 12 weeks