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Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

Primary Purpose

Contrast-Induced Acute Kidney Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CRMD-001-Deferiprone
Placebo
Sponsored by
CorMedix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contrast-Induced Acute Kidney Injury focused on measuring Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Care Group, St. Vincent's Hospital
  • St. John Hospital and Medical Center
  • Cardiac and Vascular Research Center of Northern Michigan
  • Providence Hospital
  • Ohio Health Research Institute
  • Cardiovascular Catheterization Labs at Fairfield
  • St. Vincent Mercy Medical Center
  • Oklahoma Cardiovascular Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CRMD-001-Deferiprone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Biomarker evidence of Acute Kidney injury
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

Incidence of Acute Kidney Injury
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

Full Information

First Posted
June 16, 2010
Last Updated
June 23, 2011
Sponsor
CorMedix
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1. Study Identification

Unique Protocol Identification Number
NCT01146925
Brief Title
Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CorMedix

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-Induced Acute Kidney Injury
Keywords
Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRMD-001-Deferiprone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CRMD-001-Deferiprone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
Primary Outcome Measure Information:
Title
Biomarker evidence of Acute Kidney injury
Description
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
Time Frame
8 Days
Secondary Outcome Measure Information:
Title
Incidence of Acute Kidney Injury
Description
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
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older eGFR of < 60 ml/min/1.73 m2 Presence of at least one additional risk factor: Diabetes Mellitus Age ≥ 75 years Left Ventricular Ejection Fraction ≤ 40% Exclusion Criteria: End-Stage Renal Disease Recent change in serum creatinine Primary PCI for STEMI Currently receiving mechanical ventilation Severe heart failure of cardiogenic shock Requirement for inotropic support (prior 30 days) Sustained hypertension > or = 200/110 Subject not expected to live for 90 days Anticipated use of ioxaglate or iohexol Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid Absolute neutrophil count < 1500 Hemoglobin < 8 gm/dL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. McCullough, MD, MPH
Organizational Affiliation
St. John Providence Health System, Novi, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Care Group, St. Vincent's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
St. John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Cardiac and Vascular Research Center of Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Cardiovascular Catheterization Labs at Fairfield
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45104
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States

12. IPD Sharing Statement

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Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury

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