NCT00416520

A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)	3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
DRUG	Placebo	3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
DRUG	Another phosphate binder (Sevelamer)	Current approved dosing recommendations for 12 weeks

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2006-12-28
• Last updated: 2026-01-08
• Results posted: 2014-10-23

Locations

68 sites across 11 countries: Australia, Austria, Czechia, France, Germany, Hungary, Italy, Poland, South Africa, Spain, United Kingdom