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

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