NCT00324376

Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Sevelamer hydrochloride

Timeline

• Start date: 2003-03-01
• Completion: 2004-05-01
• First posted: 2006-05-11
• Last updated: 2015-03-05

Locations

2 sites across 1 country: United States