CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 203 enrolled
Drug / intervention
calcium acetate +2 moredrug
Likely dose
calcium acetate 667 mgfrom 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/NCT00211939
NCT00211939Phase 4Completed
CompareCT.gov

CARE-2 (Calcium Acetate (PhosLo®)/Sevelamer(Renagel®) Evaluation Study 2)

Nabi Biopharmaceuticals·interventional·Posted Sep 21, 2005·Updated Jan 8, 2008

In Brief

A Phase 4 clinical trial evaluating calcium acetate, sevelamer, and 1 other intervention for Calcinosis and 2 related conditions. Completed, enrolled 203 participants across 1 site.

Detailed Summary

The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCalcinosis, Arteriosclerosis, Hyperparathyroidism, Secondary
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2006
Study CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.8 years ago

Interventions

calcium acetatedrug

667 mg gelcap, 2-4 t.i.d titrated to serum phosphorus level

sevelamerdrug

1-3 tablets t.i.d, titrated to serum phosphorus level

atorvastatindrug

20 mg PO qD (in PhosLo group), or held until D60 (sevelamer group); titrate by LDL levels and liver function tests