Clinical Trials Directory

Trials / Completed

CompletedNCT00196755

Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis

An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared With Calcium Acetate in Peritoneal Dialysis Patients

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

Summary

The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.

Conditions

Interventions

TypeNameDescription
DRUGSevelamer Hydrochloride (Renagel®)Sevelamer hydrochloride three times per day with each meal
DRUGCalcium acetate (PhosLo® )Calcium acetate three times per day with each meal

Timeline

Start date
2004-12-01
Primary completion
2006-03-01
Completion
2006-04-01
First posted
2005-09-20
Last updated
2015-03-18

Locations

17 sites across 7 countries: Belgium, Denmark, France, Italy, Netherlands, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT00196755. Inclusion in this directory is not an endorsement.