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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391520

Enrollment

Registered

2011-07-12

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone

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.

Interventions

DRUGdeferiprone

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026