QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

Protocol: 
NCT02610283
Phase: 
II

QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

To Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury Following Cardiac Surgery

Are you Eligible? (Inclusion Criteria)

  • Age over 45 yrs
  • Stable kidney function
  • Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:
    • Combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery) and at least 1 AKI Risk Factor;
    • Surgery of more than one cardiac valve (valve surgery) and at least 1 AKI Risk Factor;
    • Surgery of the aortic root or ascending part of the aorta, or aortic valve, including circulatory arrest and at least 1 AKI Risk Factor;
    • Aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, including circulatory arrest and at least 1 AKI Risk Factor;
    • If only CABG or single valve surgery, subjects are required to have at least 2 AKI Risk Factors:

      AKI Risk Factors:

      • Age ≥ 70 years
      • eGFR ≤ 60 ml/min/1.73m2 by CKD-EPI formula at Screening.
      • Diabetes (Type 1 or 2), requiring at least 1 oral hypoglycemic agent or insulin
      • Proteinuria ≥ 0.3g/d, spot UPCR ≥ 0.3g/gm or urine dip stick ≥ +2
      • History of congestive heart failure requiring hospitalization

Specialty Area(s)

Trial Location

NewYork-Presbyterian/Columbia University Medical Center
Department of Surgery
New York, NY 10032
United States