drugset / Trial / NCT01391520

Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent

NCT01391520

Phase 3 Withdrawn CorMedix
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in a composite of specified renal and cardiovascular clinical events occurring through Day 90.

Timeline

Start
2012-01
Primary completion
2013-03
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferiprone Small molecule 2700 mg

Indications