Status:
COMPLETED
Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury
Lead Sponsor:
CorMedix
Conditions:
Contrast-Induced Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 coro...
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. Adul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01146925
Start Date
June 1 2010
End Date
June 1 2011
Last Update
June 27 2011
Active Locations (8)
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1
The Care Group, St. Vincent's Hospital
Indianapolis, Indiana, United States, 46290
2
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
3
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
4
Providence Hospital
Southfield, Michigan, United States, 48075