Clinical trial NCT01146925: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contrast-Induced Acute Kidney Injury
Keywords: Acute Kidney Injury
Contrast-Induced Nephropathy
Labile Iron
Iron Chelation
Deferiprone
Lead sponsor: CorMedix
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarker evidence of Acute Kidney injury
timeFrame: 8 Days
Secondary outcomes:
measure: Incidence of Acute Kidney Injury
timeFrame: 48 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: The Care Group, St. Vincent's Hospital
state: Indiana
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Cardiac and Vascular Research Center of Northern Michigan
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Fairfield
country: United States
facility: Cardiovascular Catheterization Labs at Fairfield
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
Study officials:
affiliation: St. John Providence Health System, Novi, MI
name: Peter A. McCullough, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: