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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01391520
• Other study ID #: CRMD001-3001
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2020
• Source: CorMedix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CorMedix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of renal and cardiovascular clinical events occurring through Day 90		Day 90 following index cardiac catheterization