drugset / Trial / NCT02332811

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

NCT02332811

Phase 3 Completed 96 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis Secondary Objective: Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)

Timeline

Start
2013-10
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject sevelamer Other / unclassified 800 mg Oral
Subject sevelamer Other / unclassified 2.4 g Oral