A Study of THR-184 in Patients at Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)

Inclusion Criteria

• Male or female and >18 years of age.
• Scheduled for a non-emergent coronary and/or valve surgery procedure requiring CPB, to include:
• coronary artery bypass graft (CABG) alone;
• aortic valve replacement or repair alone, with or without aortic root repair;
• mitral, tricuspid, or pulmonic valve replacement or repair alone;
• simultaneous replacement of several cardiac valves;
• CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair;
• CABG with combined cardiac valve replacement or repair.
• Have the following risk factors for CSA-AKI:
• eGFR ≥ 20 and 85 years;
• Weight >174 kg or 383 lbs;
• The presence of AKI (KDIGO criteria) at the time of screening ;
• Surgery to be performed without CPB;
• Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature 120 beats per minute (bpm) and requirement for inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP);
• Requirement for any of the following within seven (7) days prior to cardiac surgery:
• defibrillator or permanent pacemaker,
• mechanical ventilation,
• intra-aortic balloon counter-pulsation (IABP),
• left ventricular assist device (LVAD),
• other forms of mechanical circulatory support (MCS);
• Cardiopulmonary resuscitation within 14 days prior to cardiac surgery;
• Known history of cancer within the past 5 years, except for carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin;
• Known or suspected sepsis at time of screening;
• Known or suspected glomerulonephritis or interstitial nephritis at time of screening;
• Confirmed or treated endocarditis within previous 30 days prior to cardiac surgery;
• Other current active infection requiring antibiotic treatment;
• Patients with known active human immunodeficiency virus infection;
• Documented history of HIV antibodies;
• Patients with known active Hepatitis B (HBV) or Hepatitis C (HCV) infection;
• Documented history of HCV antibodies;
• Documented history of HBV antigens;
• Patients on immunosuppressant drugs or prednisone over the dose of 20 mg per day;
• Inadequate hepatic function, defined as total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening or Child Pugh Class C liver disease ( see appendix 6) or higher;
• Any congenital coagulation disorder;
• Pregnancy or lactation;
• If patient has "Do Not Resuscitate" (DNR) status;
• Known hypersensitivity to the study drug or any of its excipients;
• Treatment with an investigational drug or participation in an interventional trial within 60 days prior to 1st dose of study drug;
• In the opinion of the investigator any disease processes or confounding variables that would inappropriately alter the outcome of the study;
• Inability to comply with the requirements of the study protocol.