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A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI) and Major Adverse Kidney Events (MAKE)

RECRUITING
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40 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
• 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 \[hemoglobin \<10 grams/deciliters (g/dL)\]
• Stable kidney function with no known episodes of AKI within 2 weeks of screening
Exclusion Criteria:

• Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
• Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
• Presence of a durable left ventricular assist device
• Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
• Heart transplant
• Transcatheter valve replacements
• Hypotension or shock requiring hospital admission
• Cardiopulmonary resuscitation
• eGFR \< 20 mL/min/1.73 m\^2
• Heart failure with ejection fraction \< 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
• History of kidney transplant or only one kidney (due to donation)
• Renal agenesis, total nephrectomy, or partial nephrectomy of \> 50%

DRUG: GDC-8264, DRUG: Placebo

Acute Kidney Injury

Reference Study ID Number: GC45428 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com
NCT06602453

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