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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcium acetate oral solution (COS)
Sevelamer carbonate
Sponsored by
Fresenius Medical Care North America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Serum phosphorus levels

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Raphael's Dialysis Center
  • North Haven Dialysis
  • Irving Place Dialysis Center
  • Upper Manhattan Dialysis Clinic (UMDC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phoslyra - Calcium Acetate Oral Solution

Sevelamer Carbonate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Serum Phosphorus Levels
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject

Secondary Outcome Measures

Full Information

First Posted
August 31, 2011
Last Updated
December 11, 2015
Sponsor
Fresenius Medical Care North America
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1. Study Identification

Unique Protocol Identification Number
NCT01427907
Brief Title
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care North America

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Serum phosphorus levels

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phoslyra - Calcium Acetate Oral Solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Sevelamer Carbonate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium acetate oral solution (COS)
Other Intervention Name(s)
Phoslyra
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Renvela
Intervention Description
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).
Primary Outcome Measure Information:
Title
Serum Phosphorus Levels
Description
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Katanko, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Raphael's Dialysis Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
North Haven Dialysis
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Irving Place Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Upper Manhattan Dialysis Clinic (UMDC)
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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