Chronic Kidney Disease Clinical Trial
Official title:
Randomized,Multi-center,Phase IV, 2-arm,Open-Label,Cross-over Study to Demonstrate the Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and
sevelamer carbonate in maintaining serum phosphorus levels
This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the
equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer
carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim
of the study is to maintain serum phosphorus level and establish equivalence between COS and
sevelamer carbonate tablets.
Total 40 subjects will be randomized for participation into the study The subjects are Hemo-dialysis Dependent Chronic Kidney Disease (CKD) Stage 5D patients who are able to give informed consent to the study, and taking the phosphate binder sevelamer carbonate tablets. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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