Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients (COS-002)
Chronic Kidney Disease
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Serum phosphorus levels
Eligibility Criteria
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.
Sites / Locations
- St. Raphael's Dialysis Center
- North Haven Dialysis
- Irving Place Dialysis Center
- Upper Manhattan Dialysis Clinic (UMDC)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Phoslyra - Calcium Acetate Oral Solution
Sevelamer Carbonate
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 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.