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

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.

Inclusion Criteria:

1. Age 18 or older

2. eGFR of < 60 ml/min/1.73 m2

3. Presence of at least one additional risk factor:

   • Diabetes Mellitus
   • Age ≥ 75 years
   • Left Ventricular Ejection Fraction ≤ 40%

Exclusion Criteria:

1. End-Stage Renal Disease
2. Recent change in serum creatinine
3. Primary PCI for STEMI
4. Currently receiving mechanical ventilation
5. Severe heart failure of cardiogenic shock
6. Requirement for inotropic support (prior 30 days)
7. Sustained hypertension > or = 200/110
8. Subject not expected to live for 90 days
9. Anticipated use of ioxaglate or iohexol
10. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid
11. Absolute neutrophil count < 1500
12. Hemoglobin < 8 gm/dL