drugset / Trial / NCT00268957

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

NCT00268957

Phase 3 Completed 217 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-01
Primary completion
2007-03
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sevelamer Other / unclassified
Subject sevelamer Other / unclassified