A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery

Inclusion Criteria:

- Subject must be male or female, age greater than or equal to 18 years old.

- Subjects must have stable renal function, per Investigator discretion and no known
increase in serum creatinine of greater than or equal to 0.3 mg during the preceding
4 weeks.

- Subjects with estimated glomerular filtration rate less than or equal to 60
mL/min/1.73 m2 who require intravascular iodinated contrast within 48 hours of the
day of surgery, will only be included if there is no known serum creatinine increase
greater than or equal to 0.3 mg.

- Subjects must be undergoing a pre-defined on-pump cardiac surgery meeting one of the
following acute kidney injury risk factors:

- Subject is undergoing combined coronary artery bypass grafting (CABG) surgery and
surgery of one or more cardiac valve (valve(s) surgery), or

- Subject is undergoing surgery of more than one cardiac valve (valves surgery), or

- Subject is undergoing surgery of the aortic root or ascending part of the aorta, or

- Subject is undergoing surgery of the aortic root or ascending part of the aorta,
combined with coronary artery bypass graft and/or valve(s) surgery, or

- Subject has an estimated glomerular filtration rate greater than or equal to 16
mL/min/1.73 m2 and less than or equal to 59 mL/min/1.73 m2 as determined by Chronic
Kidney Disease Epidemiology Collaboration (CKD EPI) formula at Screening, and is
undergoing coronary artery bypass graft or single valve surgery.

Exclusion Criteria:

- Has an eGFR less than or equal to 15 mL/min/1.73 m2.

- Cardiac surgery to be performed without cardiopulmonary bypass.

- Has ongoing sepsis or history of sepsis within the last 2 weeks or untreated
diagnosed infection prior to Screening visit. Sepsis is defined as presence of a
confirmed pathogen, along with fever or hypothermia, and hypoperfusion or
hypotension.

- Has known or documented RIFLE "R" or AKIN "Stage I" within the previous 4 weeks.

- Recently received (within the last 10 weeks) or is anticipated to receive
chemotherapy which can interfere with kidney function