Status:
COMPLETED
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Lead Sponsor:
Fresenius Medical Care North America
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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, op...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01427907
Start Date
September 1 2011
End Date
July 1 2012
Last Update
January 14 2016
Active Locations (4)
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1
St. Raphael's Dialysis Center
New Haven, Connecticut, United States, 06511
2
North Haven Dialysis
North Haven, Connecticut, United States, 06473
3
Irving Place Dialysis Center
New York, New York, United States, 10003
4
Upper Manhattan Dialysis Clinic (UMDC)
New York, New York, United States, 10025