NCT01146925

Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of CRMD-001 in Contrast-Induced Acute Oxidative Kidney Injury

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CorMedix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.

Detailed description

This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 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 mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.

Conditions

• Contrast-Induced Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	CRMD-001-Deferiprone	CRMD-001 represents unique formulations of Deferiprone. Subjects will be given one (900 mg) immediate release and two (900 mg) extended release tablets 1-3 hours prior to angiography and then every 12 hours for a total of 8 days
DRUG	Placebo	3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-06-22
• Last updated: 2011-06-27

Locations

8 sites across 1 country: United States