NCT01736150

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

A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Chronic Kidney Disease on Hemodialysis

Interventions

Type	Name	Description
DRUG	Placebo	* Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.
DRUG	Sevelamer carbonate	* Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2012-11-29
• Last updated: 2015-03-23

Locations

18 sites across 1 country: China