Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
NCT00196755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2015-03-18
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
- Peritoneal Dialysis
- Chronic Kidney Disease
Interventions
- DRUG
-
Sevelamer Hydrochloride (Renagel®)
Sevelamer hydrochloride three times per day with each meal
- DRUG
-
Calcium acetate (PhosLo® )
Calcium acetate three times per day with each meal
Sponsors & Collaborators
-
Genzyme, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Genzyme, a Sanofi Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
- Primary Completion
- 2006-03-31
- Completion
- 2006-04-30
Countries
- Belgium
- Denmark
- France
- Italy
- Netherlands
- Spain
- United Kingdom
Study Locations
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