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

Chronic Kidney Disease Clinical Trial

— COS-002  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427907
• Other study ID #: COS-002
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2011
• Last updated: December 11, 2015
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2015
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Calcium acetate oral solution (COS)
Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
• Sevelamer carbonate
Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).

Locations

Country	Name	City	State
United States	St. Raphael's Dialysis Center	New 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	North Haven Dialysis	North Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Phosphorus Levels	The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject	2 weeks	No