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

Phase 3

Withdrawn

• Conditions: Acute Kidney Injury
• Interventions: Drug: Placebo; Drug: deferiprone

• Registration Number: NCT01391520
• Lead Sponsor: CorMedix

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-12
• Study Start: 2012-01
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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
CRMD001-Deferiprone	deferiprone	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

Primary Outcome Measures

Name	Time	Method
A composite of renal and cardiovascular clinical events occurring through Day 90	Day 90 following index cardiac catheterization