NCT00451295

A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

Conditions

• Chronic Kidney Disease
• Dialysis
• 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
DRUG	Placebo	3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-03-23
• Last updated: 2011-11-15

Locations

25 sites across 10 countries: Czechia, France, Germany, Italy, North Macedonia, Poland, Serbia, South Africa, Spain, United Kingdom