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

Completed · Phase 4

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01427907

Run by

Fresenius Medical Care North America

People needed

38

Starts

2011-09-01

Expected to finish

2012-07-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Raphael's Dialysis Center — New Haven, Connecticut, United States
• North Haven Dialysis — North Haven, Connecticut, United States
• Irving Place Dialysis Center — New York, New York, United States
• Upper Manhattan Dialysis Clinic (UMDC) — New York, New York, United States

Full record on ClinicalTrials.gov

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