Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Completed
Fresenius Medical Care North America
Phase 4
2011-09-01
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.
A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia
Terminated
Vifor Fresenius Medical Care Renal Pharma
Phase 3
2016-05-26
This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre
Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate
(Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of
this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in
paediatric and adolescent patients with CKD, and to provide safety and dosing information for
this patient population. The Phoslyra (comparator) group provides information for a
descriptive comparison of PA21 against a commonly used calcium-based phosphate binder
(calcium acetate).
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