drugset / Trial / NCT01574326

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

NCT01574326 ↗

Phase 2 Completed 101 enrolled Genzyme, a Sanofi Company
RandomizedSingle-groupDouble-blindTreatment

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

Timeline

Start
2012-05
Primary completion
2015-06
Completion
2015-06

Outcome

Met primary endpoint

registry FDP-Placebo for Sevelamer Carbonate vs FDP-Sevelamer Carbonate; p = 0.001; Least square (LS) mean difference -0.9 (95% CI -1.44 to -0.37) NCT01574326 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject sevelamer Other / unclassified 0.8 g Oral