Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.

This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or placebo after the completion of cardiovascular 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