CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
Calcium acetate oral solution (COS) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01427907
NCT01427907Phase 4Completed
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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

Fresenius Medical Care North America·interventional·Posted Sep 2, 2011·Updated Jan 14, 2016

In Brief

A Phase 4 clinical trial evaluating Calcium acetate oral solution (COS) and Sevelamer carbonate for Chronic Kidney Disease. Completed, enrolled 38 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2011
Enrollment StartSep 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.8 years ago

Interventions

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).

Sevelamer carbonatedrug

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).