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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.
Details
| Lead sponsor | CorMedix |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2010-06 |
| Completion | 2011-06 |
Conditions
- Contrast-Induced Acute Kidney Injury
Interventions
- CRMD-001-Deferiprone
- Placebo
Primary outcomes
- Biomarker evidence of Acute Kidney injury — 8 Days
Mean paired change in a panel of acute kidney injury (AKI) biomarkers (urinary NGAL, LFABP, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), urinary alpha GST (proximal tubular injury), Pi GST (distal tubular injury) and cystatin C; serum cystatin C) from baseline (Day 1) to peak in the deferiprone and placebo treatment groups, within 192 hours of contrast exposure
Countries
United States