Phase 4 N=38 Randomized Treatment

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

Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01427907 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Jan 2016

Primary outcome: Primary: Serum Phosphorus Levels — 4.6; 4.6 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Calcium acetate oral solution (COS) (Drug); Sevelamer carbonate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fresenius Medical Care North America
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Phosphorus Levels	4.6; 4.6	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01427907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.