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

Sponsor

CorMedix (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01391520

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: deferiprone Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

A composite of renal and cardiovascular clinical events occurring through Day 90 [Day 90 following index cardiac catheterization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%

Exclusion Criteria:

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