NCT00833768

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

Conditions

• Chronic Kidney Disease
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	Sevelamer carbonate	800mg tablets to be taken orally with meals three times per day
DRUG	Placebo for sevelamer carbonate	Placebo tablets to be taken orally with meals three times per day

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-02-02
• Last updated: 2015-03-24

Locations

36 sites across 9 countries: Austria, France, Germany, Greece, Hungary, Italy, Portugal, Spain, Sweden