NCT00772382

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

A Phase III, Multi-center, 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: 116 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia. The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Conditions

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	MCI-196	3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-10-15
• Last updated: 2026-01-08
• Results posted: 2014-05-12

Locations

21 sites across 2 countries: United States, Canada