Chronic Kidney Disease Clinical Trial
Official title:
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
Objective: In hyperphosphatemic pediatric patients 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
The study is 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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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