Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01146925
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : June 27, 2011
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Brief Summary:
The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.

Condition or disease Intervention/treatment Phase
Contrast-Induced Acute Kidney Injury Drug: CRMD-001-Deferiprone Drug: Placebo Phase 2

Detailed Description:
This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 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 mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of CRMD-001 in Contrast-Induced Acute Oxidative Kidney Injury
Study Start Date : June 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Deferiprone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CRMD-001-Deferiprone Drug: CRMD-001-Deferiprone
CRMD-001 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
Placebo Comparator: Placebo Drug: Placebo
3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography

Primary Outcome Measures :
  1. Biomarker evidence of Acute Kidney injury [ Time Frame: 8 Days ]
    Mean paired change in a panel of acute kidney injury (AKI) biomarkers (urinary NGAL, LFABP, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), urinary alpha GST (proximal tubular injury), Pi GST (distal tubular injury) and cystatin C; serum cystatin C) from baseline (Day 1) to peak in the deferiprone and placebo treatment groups, within 192 hours of contrast exposure

Secondary Outcome Measures :
  1. Incidence of Acute Kidney Injury [ Time Frame: 48 hours ]
    Incidence of AKI defined as an absolute increase in serum Cr of ≥ 0.3 mg/dL, and/or a 50% relative increase in serum Cr from baseline (Day 1) to a maximum value obtained within 48 hours of contrast exposure

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 or older
  2. eGFR of < 60 ml/min/1.73 m2
  3. Presence of at least one additional risk factor:

    • Diabetes Mellitus
    • Age ≥ 75 years
    • Left Ventricular Ejection Fraction ≤ 40%

Exclusion Criteria:

  1. End-Stage Renal Disease
  2. Recent change in serum creatinine
  3. Primary PCI for STEMI
  4. Currently receiving mechanical ventilation
  5. Severe heart failure of cardiogenic shock
  6. Requirement for inotropic support (prior 30 days)
  7. Sustained hypertension > or = 200/110
  8. Subject not expected to live for 90 days
  9. Anticipated use of ioxaglate or iohexol
  10. Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid
  11. Absolute neutrophil count < 1500
  12. Hemoglobin < 8 gm/dL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01146925

United States, Indiana
The Care Group, St. Vincent's Hospital
Indianapolis, Indiana, United States, 46290
United States, Michigan
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
Providence Hospital
Southfield, Michigan, United States, 48075
United States, Ohio
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Cardiovascular Catheterization Labs at Fairfield
Fairfield, Ohio, United States, 45104
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
Sponsors and Collaborators
Principal Investigator: Peter A. McCullough, MD, MPH St. John Providence Health System, Novi, MI

Responsible Party: Robert Hopkins, DVM, MS/Head Clinical Operations and Project Management, CorMedix Identifier: NCT01146925     History of Changes
Other Study ID Numbers: CRMD-001-2001
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by CorMedix:
Acute Kidney Injury
Contrast-Induced Nephropathy
Labile Iron
Iron Chelation

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action