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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care North America
ClinicalTrials.gov Identifier:
NCT01427907
First received: August 31, 2011
Last updated: December 11, 2015
Last verified: December 2015
  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: Calcium acetate oral solution (COS)
Drug: Sevelamer carbonate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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:


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

Primary Outcome Measures:
  • Serum Phosphorus Levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject


Enrollment: 38
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phoslyra - Calcium Acetate Oral Solution
The investigational compound is calcium acetate oral solution (COS) or Phoslyra. It is a pale, light greenish-yellow clear liquid with a characteristic black cherry odor and flavor for oral ingestion. Each 5 mL of COS contains 667 mg calcium acetate equal to 169 mg of elemental calcium. Each subject will follow their usual prescription.COS will be taken either prior to or during meals and snacks.
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).
Other Name: Phoslyra
Active Comparator: Sevelamer Carbonate
Sevelamer carbonate is an anion exchange resin that binds phosphate in the gastrointestinal tract and is a buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in End-Stage Renal Disease (ESRD) patients. Each film-coated tablet of sevelamer carbonate (trade name Renvela™) contains 800 mg of sevelamer carbonate on an anhydrous basis. Subjects will receive sevelamer tablets according to their prescription.
Drug: 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).
Other Name: Renvela

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   (Adult, Senior)
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Irving Place Dialysis Center
New York, New York, United States, 10003
Upper Manhattan Dialysis Clinic (UMDC)
New York, New York, United States, 10025
Sponsors and Collaborators
Fresenius Medical Care North America
Investigators
Principal Investigator: Peter Katanko, MD Renal Research Institute
  More Information

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
Results First Received: March 11, 2015
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Pharmaceutical Solutions
Calcium, Dietary
Sevelamer
Calcium acetate
Bone Density Conservation Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2016