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

NCT01391520 | Withdrawn Phase 3

• 1 other identifier: CRMD001-3001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• A composite of renal and cardiovascular clinical events occurring through Day 90

  Day 90 following index cardiac catheterization

Study Arms (2)

CRMD001-Deferiprone

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

deferiprone DRUG

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

CRMD001-Deferiprone

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• eGFR between 15 ml/min/1.73 m2 and \< 60 ml/min/1.73 m2
• Presence of at least one additional risk factor:
• Diabetes Mellitus type 1 or 2
• Age ≥ 75 years
• Left Ventricular Ejection Fraction ≤ 40%

You may not qualify if:

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

Sponsors & Collaborators

• CorMedix: lead

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Deferiprone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyridones; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 24, 2020

Record last verified: 2020-08