NCT00542386

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (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 two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Conditions

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	MCI-196	3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
DRUG	Placebo	3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Timeline

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

Locations

73 sites across 8 countries: Hungary, Italy, Malaysia, North Macedonia, Poland, Russia, Serbia, Ukraine