CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
sevelamer carbonate +1 moredrug
Likely dose
sevelamer carbonate 2400 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/NCT01191762
NCT01191762Phase 3Completed

The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism

Kenneth R. Phelps, M.D.·interventional·Posted Aug 31, 2010·Updated Nov 1, 2016

In Brief

A Phase 3 clinical trial evaluating sevelamer carbonate and placebo for Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal \[PTH\]to maintain normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal phosphate binder sevelamer carbonate will be employed to examine whether reductions in phosphate influx alter distal nephron phosphate concentration and the \[PTH\] required for calcium reabsorption in the expected manner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2010
Enrollment StartApr 1, 2010
Primary CompletionAug 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.8 years ago

Interventions

sevelamer carbonatedrug

2400 mg with each meal for 4 weeks

placebodrug

3 tablets with each meal