A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis
Overview
- Phase
- Phase 3
- Intervention
- Sevelamer carbonate
- Conditions
- Chronic Kidney Disease
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 205
- Locations
- 18
- Primary Endpoint
- Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study
- •Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1
- •Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a
Exclusion Criteria
- •Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation
- •Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition
Arms & Interventions
Sevelamer carbonate
Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.
Intervention: Sevelamer carbonate
Placebo
Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous.
Time Frame: 8 weeks
Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs.
Time Frame: 11 weeks
Secondary Outcomes
- Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol).(8 weeks)