Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury
| Status: | Archived |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | June 2010 |
| End Date: | March 2011 |
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
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.
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.
We found this trial at
8
sites
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Providence Hospital St. John Providence Health System is comprised of five hospitals plus more than...
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