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Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients (COS-002)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care North America
ClinicalTrials.gov Identifier:
NCT01427907
First received: August 31, 2011
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: Phoslyra
Drug: Sevelamer Carbonate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fresenius Medical Care North America:

Primary Outcome Measures:
  • Treatment-related severe adverse events for sevelamer and COS [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment-related adverse events for sevelamer and COS [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phoslyra - Calcium Acetate Oral Solution Drug: Phoslyra
The investigator communicates and decides with the original treating physician any treatment changes
Active Comparator: Sevelamer Carbonate Drug: Sevelamer Carbonate
The investigator communicates and decides with the original treating physician any treatment changes.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427907

Locations
United States, Connecticut
St. Raphael's Dialysis Center
New Haven, Connecticut, United States, 06511
North Haven Dialysis
North Haven, Connecticut, United States, 06473
United States, New York
Upper Manhattan Dialysis Clinic (UMDC)
New York, New York, United States, 10025
Irving Place Dialysis Center
New York, New York, United States, 10003
Sponsors and Collaborators
Fresenius Medical Care North America
  More Information

No publications provided

Responsible Party: Fresenius Medical Care North America
ClinicalTrials.gov Identifier: NCT01427907     History of Changes
Other Study ID Numbers: COS-002
Study First Received: August 31, 2011
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Fresenius Medical Care North America:
Serum phosphorus levels

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Sevelamer
Calcium acetate
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013