Conditions: Hyperphosphatemia Chronic Kidney Disease
Keywords: Chronic Kidney Disease Pediatric Sevelamer Carbonate Hyperphosphatemia
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 101
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). arm 2: Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.

Interventions: intervention 1: Placebo intervention 2: Sevelamer carbonate
Intervention descriptions: intervention 1: Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets intervention 2: 0.8 g sachets of powder for oral suspension or 800 mg tablets

Protocol document: