Back to resultsEfficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent
Primary Purpose
Acute Kidney Injury
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
deferiprone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CRMD001-Deferiprone
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
A composite of renal and cardiovascular clinical events occurring through Day 90
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01391520
Brief Title
Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor encountered funding issues for this study.
Study Start Date
January 2012 (Anticipated)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CorMedix
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRMD001-Deferiprone
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
deferiprone
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
A composite of renal and cardiovascular clinical events occurring through Day 90
Time Frame
Day 90 following index cardiac catheterization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent
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