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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Medical Care North America
• Treatments: Calcium; Calcium acetate; Calcium, Dietary; Pharmaceutical Solutions; Sevelamer

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.