QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery

Key Inclusion Criteria: * Male or female, age ≥ 18 years old * At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors: * Reduced renal function * Diabetes with ongoing insulin treatment * Albuminuria * Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest Key Exclusion Criteria: * Emergent surgeries, including aortic dissection, and major congenital heart defects * Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects \<45 years old is allowed.) * Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated