NCT00267514

Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients

A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)	sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
DRUG	sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)	sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-03-01
• Completion: 2007-05-01
• First posted: 2005-12-21
• Last updated: 2015-03-18

Locations

7 sites across 1 country: United Kingdom