Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients (COS-002)

Fresenius Medical Care (FMC)

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Calcium acetate oral solution (COS); Drug: Sevelamer carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427907

COS-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Phoslyra - Calcium Acetate Oral Solution

Experimental group

Description:

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.

Treatment:

Drug: Calcium acetate oral solution (COS)

Sevelamer Carbonate

Active Comparator group

Description:

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.

Treatment:

Drug: Sevelamer carbonate