NCT00440648

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

Detailed description

The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	sevelamer carbonate, sevelamer hydrochloride	Starting dose individualized for each patient and fixed daily dose throughout both treatment periods
DRUG	sevelamer hydrochloride, sevelamer carbonate	Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-03-01
• Completion: 2006-07-01
• First posted: 2007-02-27
• Last updated: 2014-03-19

Locations

15 sites across 1 country: United States