Conditions: Chronic Kidney Disease
Keywords: Serum phosphorus levels
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 38
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: The investigational compound is calcium acetate oral solution (COS) or Phoslyra. It is a pale, light greenish-yellow clear liquid with a characteristic black cherry odor and flavor for oral ingestion. Each 5 mL of COS contains 667 mg calcium acetate equal to 169 mg of elemental calcium. Each subject will follow their usual prescription.COS will be taken either prior to or during meals and snacks. arm 2: Sevelamer carbonate is an anion exchange resin that binds phosphate in the gastrointestinal tract and is a buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in End-Stage Renal Disease (ESRD) patients. Each film-coated tablet of sevelamer carbonate (trade name Renvela™) contains 800 mg of sevelamer carbonate on an anhydrous basis. Subjects will receive sevelamer tablets according to their prescription.

Interventions: intervention 1: Calcium acetate oral solution (COS) intervention 2: Sevelamer carbonate
Intervention descriptions: intervention 1: Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2). intervention 2: Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).

Protocol document: