Clinical trial NCT01427907: Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Official title: Randomized,Multi-center,Phase IV, 2-arm,Open-Label,Cross-over Study to Demonstrate the Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Serum phosphorus levels
Lead sponsor: Fresenius Medical Care North America
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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, 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.

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 the study, and taking the phosphate binder sevelamer carbonate tablets.

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.

Primary outcomes:
measure: Serum Phosphorus Levels
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: St. Raphael's Dialysis Center
state: Connecticut
city: North Haven
country: United States
facility: North Haven Dialysis
state: Connecticut
city: New York
country: United States
facility: Irving Place Dialysis Center
state: New York
city: New York
country: United States
facility: Upper Manhattan Dialysis Clinic (UMDC)
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Katanko, MD
role: PRINCIPAL_INVESTIGATOR
References: