NCT00441545

Head to Head Study Against Sevelamer Hydrochloride

A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Detailed description

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Conditions

• Chronic Kidney Disease, Stage 5

Interventions

Type	Name	Description
DRUG	Fosrenol (Lanthanum Carbonate)	The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
DRUG	Sevelamer hydrochloride	The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.

Timeline

• Start date: 2007-01-05
• Primary completion: 2008-07-31
• Completion: 2008-07-31
• First posted: 2007-03-01
• Last updated: 2021-06-11
• Results posted: 2009-08-13

Locations

44 sites across 4 countries: United States, Germany, Puerto Rico, United Kingdom