Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Sevelamer

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