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

NCT ID: NCT01391520

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

deferiprone

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CorMedix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CRMD001-3001

Identifier Type: -

Identifier Source: org_study_id