A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Deferiprone in the Reduction of Morbidity and Mortality in Patients With Chronic Kidney Disease Undergoing Diagnostic or Interventional Cardiac Procedures and Receiving an Iodinated Radiocontrast Agent

NCT01391520 Phase 3 WITHDRAWN

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.

Details

Lead sponsor	CorMedix
Phase	Phase 3
Status	WITHDRAWN
Start date	2012-01
Completion	2013-06

Conditions

• Acute Kidney Injury

Interventions

• deferiprone
• Placebo

Primary outcomes

• A composite of renal and cardiovascular clinical events occurring through Day 90 — Day 90 following index cardiac catheterization