NCT01574326

An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to * Evaluate the safety and tolerability of sevelamer carbonate * Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

Detailed description

The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.

Conditions

• Hyperphosphatemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Placebo	Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
DRUG	Sevelamer carbonate	0.8 g sachets of powder for oral suspension or 800 mg tablets

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-04-10
• Last updated: 2016-07-25
• Results posted: 2016-07-25

Locations

32 sites across 5 countries: United States, France, Germany, Lithuania, Poland