Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

Phase 4

Completed

Interventions: Drug: Calcium acetate oral solution (COS)
Drug: Sevelamer carbonate

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.

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects ≥18 years of age able to give written informed consent to the study
Hemodialysis dependent chronic kidney disease stage 5D patients
Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy
Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day

Exclusion Criteria

Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status >1
Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not exclusionary. History of malignancy is not an exclusion
Known hypersensitivity reaction to calcium-based phosphate binders
Anticipated renal transplantation during the study
Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Arm && Interventions

Group	Intervention	Description
Phoslyra - Calcium Acetate Oral Solution	Calcium acetate oral solution (COS)	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.
Sevelamer Carbonate	Sevelamer carbonate	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.

Primary Outcome Measures

Name	Time	Method
Serum Phosphorus Levels	2 weeks	The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject

Secondary Outcome Measures

Name	Time	Method

Locations (4): Irving Place Dialysis Center
🇺🇸
New York, New York, United States
North Haven Dialysis
🇺🇸
North Haven, Connecticut, United States
Upper Manhattan Dialysis Clinic (UMDC)
🇺🇸
New York, New York, United States
St. Raphael's Dialysis Center
🇺🇸
New Haven, Connecticut, United States