Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
COS-002
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
1 other identifier
interventional
38
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2011
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
January 14, 2016
CompletedJanuary 14, 2016
December 1, 2015
10 months
August 31, 2011
March 11, 2015
December 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Phoslyra - Calcium Acetate Oral Solution
EXPERIMENTALThe 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
ACTIVE COMPARATORSevelamer 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.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status \>1
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
St. Raphael's Dialysis Center
New Haven, Connecticut, 06511, United States
North Haven Dialysis
North Haven, Connecticut, 06473, United States
Irving Place Dialysis Center
New York, New York, 10003, United States
Upper Manhattan Dialysis Clinic (UMDC)
New York, New York, 10025, United States
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The Last Patient Last Visit (LPLV) was on 06-July-2012 and last site close out visit was 31 May 2013. Due to inadvertent study deviations, no reliable conclusions can be drawn from the study.
Results Point of Contact
- Title
- Mayuri Thakuria MD (MBBS), MPH
- Organization
- Fresenius Medical Care, North America
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Katanko, MD
Renal Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2011
First Posted
September 2, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
January 14, 2016
Results First Posted
January 14, 2016
Record last verified: 2015-12