NCT00542815

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Detailed description

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Conditions

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	MCI-196	3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
DRUG	Another Phosphate binder (Sevelamer)	Current approved dosing recommendations for 12 weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-10-12
• Last updated: 2026-01-07
• Results posted: 2014-09-23

Locations

115 sites across 15 countries: Austria, Czechia, France, Germany, Hungary, Italy, Malaysia, North Macedonia, Poland, Russia, Serbia, South Africa, Spain, Ukraine, United Kingdom