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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Deferiprone in the Reduction of Morbidity and Mortality in Patients With Chronic Kidney Disease Undergoing Diagnostic or Interventional Cardiac Procedures and Receiving an Iodinated Radiocontrast Agent

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: deferiprone; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRMD001-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	Drug: deferiprone; 3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
Placebo Comparator: 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	Drug: Placebo; 3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A composite of renal and cardiovascular clinical events occurring through Day 90	Day 90 following index cardiac catheterization

Collaborators and Investigators

• Sponsor: CorMedix

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Deferiprone; Iron Chelation; Contrast-Induced Nephropathy; Labile Iron
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Deferiprone
• Other Study ID Numbers: CRMD001-3001