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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Raphael's Dialysis Center, New Haven, Connecticut, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium acetate oral solution (COS)

Drug

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 names: Phoslyra

Sevelamer carbonate

Drug

Other names: Renvela

Primary outcomes

Serum Phosphorus Levels

Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care North America

Industry

Registry information

Official study 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

Acronym: COS-002

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 2, 2011
Registry last updated: Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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