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

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ClinicalTrials.gov Identifier: NCT01391520
Recruitment Status : Withdrawn (Sponsor encountered funding issues for this study.)
First Posted : July 12, 2011
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
CorMedix

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

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : January 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Deferiprone

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




Primary Outcome Measures :
  1. A composite of renal and cardiovascular clinical events occurring through Day 90 [ Time Frame: Day 90 following index cardiac catheterization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: CorMedix
ClinicalTrials.gov Identifier: NCT01391520    
Other Study ID Numbers: CRMD001-3001
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Keywords provided by CorMedix:
Acute Kidney Injury
Contrast-Induced Nephropathy
Labile Iron
Iron Chelation
Deferiprone
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency
Deferiprone
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action