NCT00268957

Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis

A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.

Conditions

• Kidney Diseases
• Chronic Renal Insufficiency
• End-Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Sevelamer carbonate (Renvela®)	sevelamer carbonate powder dosed once per day with largest meal
DRUG	Sevelamer hydrochloride (Renagel®)	Sevelamer hydrochloride tablets dosed three times a day with meals

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-03-01
• Completion: 2007-05-01
• First posted: 2005-12-23
• Last updated: 2014-03-19

Locations

29 sites across 1 country: United States