Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

CorMedix

Status and phase: Completed; Phase 2

Conditions: Contrast-Induced Acute Kidney Injury

Treatments: Drug: CRMD-001-Deferiprone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146925

CRMD-001-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

CRMD-001-Deferiprone

Experimental group

Treatment:

Drug: CRMD-001-Deferiprone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo