NCT00506441

A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 245 (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, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Conditions

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	MCI-196	3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
DRUG	Placebo	3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-07-25
• Last updated: 2026-01-08
• Results posted: 2014-07-25

Locations

39 sites across 2 countries: United States, Puerto Rico