A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects

The study will enroll post-cardiac surgery subjects (CABG and/or valve) with laboratory
evidence of AKI within 48 hrs of removal from cardiopulmonary bypass. Subjects will be
randomly assigned (1:1 ratio) to treatment with a single administration of AC607 or placebo
(approximately 100 subjects per group).

Safety and efficacy assessments will be performed daily during the post-operative hospital
stay from the day randomized into the study until discharge, at 30 days, and at 90 days
after study drug administration (evaluation phase). Safety and long-term clinical outcomes
will be assessed at 6, 12, 24 and 36 months (long-term follow-up phase).

Inclusion Criteria:

- Age ≥ 21 years

- Had cardiovascular surgery utilizing cardiopulmonary bypass

- Have a pre-operative (baseline) serum creatinine value collected within 30 days of
surgery (if multiple laboratory results are available within this time window, the
most recent serum creatinine value prior to surgery will be used to establish the
baseline)

- Willing and able to comply with visit schedule and study procedures including
post-hospitalization discharge follow-up

- Ability to give informed consent or have a legally acceptable representative do so
for them

- Have AKI defined as ≥ 0.5 mg/dL rise in serum creatinine from baseline within 48
hours of removal from cardiopulmonary bypass

Exclusion Criteria:

- Active cancer and/or receiving active treatment for cancer, with the exception of
squamous cell or basal cell carcinoma of the skin

- Had surgery for thoraco-abdominal aortic aneurysm (TAAA)

- Currently participating in another interventional drug or device clinical study

- Prisoner or other detainee

- Has a current medical condition that would preclude or compromise femoral artery
catheter placement

- Has an intra-aortic balloon pump (IABP) in place within 2 hours of catheter placement

- Has a ventricular assist device (VAD) or extracorporeal membrane oxygenation (ECMO)
in place at the time of the study catheter placement

- Prior history of solid organ or bone marrow transplant

- Stage 5 CKD or currently on dialysis

- Are expected to receive dialysis within 24 hours of enrollment or dosing

- Had a complication during surgery or post-operatively that, in the opinion of the
principal investigator (PI), significantly increases the risk of complications to the
subject and therefore precludes dosing the subject

- Are pregnant or lactating. A woman with child-bearing potential may be tested for
pregnancy at the discretion of the PI.