Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent

CorMedix

Status and phase: Withdrawn; Phase 3

Conditions: Acute Kidney Injury

Treatments: Drug: deferiprone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391520

CRMD001-3001

Details and patient eligibility

About

This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 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 a composite of specified renal and cardiovascular clinical events occurring through Day 90.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 or older

2. eGFR between 15 ml/min/1.73 m2 and < 60 ml/min/1.73 m2

3. Presence of at least one additional risk factor:

   • Diabetes Mellitus type 1 or 2
   • Age ≥ 75 years
   • Left Ventricular Ejection Fraction ≤ 40%

Exclusion criteria

1. End-Stage Renal Disease
2. Primary PCI for STEMI
3. Currently receiving mechanical ventilation
4. Known active liver disease or liver failure
5. Evidence of hemodynamic instability, such as a requirement for pressor agents
6. Exposure to contrast media within prior 10 days
7. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, or Ascorbic acid (> 2 g/day)
8. Absolute neutrophil count < 1500

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

CRMD001-Deferiprone

Experimental group

Description:

CRMD001 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

Treatment:

Drug: deferiprone

Placebo

Placebo Comparator group

Description:

3 placebo tablets matching the appearance of the experimental treatment arm (CRMD001) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography

Treatment:

Drug: Placebo