Clinical Trials

Inclusion Criteria:
1. One of the following non-emergent cardiac surgery types that requires cardiopulmonary bypass (CPB) to be done in one procedure rather than separate procedures:  Isolated Coronary Artery Bypass Grafting (CABG); Isolated surgical Aortic Valve Replacement (AVR), Mitral Valve Replacement (MVR), Mitral Valve repair (MVr); Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, AVR+MVr
2. At least one or at least two of the following AKI risk factors, depending on the type of surgery: age > 70 years, history of CKD with eGFR < 60 milliliters/ minutes/ 1.73 meter square (ml/min/1.73 m^2) within the last 6 months, diabetes (type 1 or type 2) requiring at least one oral hypoglycemic agent or insulin, history of chronic obstructive pulmonary disease (COPD) requiring medical therapy, left ventricular ejection fraction (LVEF) < 40%, preoperative anemia {hemoglobin <10 milligrans/ deciliters (mg/dL)}
3. Stable kidney function with no known episodes of AKI within 2 weeks of screening

Exclusion Criteria:
1. Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
2. Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
3. Presence of a durable left ventricular assist device
4. Emergent cardiac surgery
5. Need for concurrent aortic surgery or repair of congenital heart defects
6. Heart transplant
7. Transcatheter valve replacements
8. Hypotension or shock requiring hospital admission
9. Cardiopulmonary resuscitation
10. eGFR < 20 mL/min/1.73 m^2
11. Heart failure with ejection fraction < 20%, or episode of decompensated heart failure requiring intervention within 2 weeks of screening
12. History of kidney transplant or only one kidney (due to donation)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.