Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
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.