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.

NCT00451295 Phase 3 TERMINATED

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.

Details

Lead sponsor	Tanabe Pharma Corporation
Phase	Phase 3
Status	TERMINATED
Enrolment	6
Start date	2007-05
Completion	2011-01

Conditions

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia

Interventions

• MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
• Placebo

Primary outcomes

• Serum phosphorus change compared to placebo from baseline to week 12. — 12 weeks

Countries

Czechia, France, Germany, Italy, North Macedonia, Poland, Serbia, South Africa, Spain, United Kingdom