Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

CorMedix60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Contrast-Induced Acute Kidney Injury

Interventions

CRMD-001-DeferiproneDRUG

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

PlaceboDRUG

3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

The Care Group, St. Vincent's Hospital

Indianapolis, Indiana, United States

St. John Hospital and Medical Center

Detroit, Michigan, United States

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Providence Hospital

Outcomes

Primary Outcomes

Biomarker evidence of Acute Kidney injury

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

Time frame: 8 Days

Secondary Outcomes

Incidence of Acute Kidney Injury

Incidence of AKI defined as an absolute increase in serum Cr of ≥ 0.3 mg/dL, and/or a 50% relative increase in serum Cr from baseline (Day 1) to a maximum value obtained within 48 hours of contrast exposure

Time frame: 48 hours

Data from ClinicalTrials.gov

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