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)

Launched by GENENTECH, INC. · Sep 17, 2024

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ClinConnect Summary

This clinical trial is studying a medication called GDC-8264 to see if it can help prevent a serious condition called acute kidney injury (AKI) in patients undergoing heart surgery. AKI can lead to major kidney problems after surgery, so this study is especially important for patients who are at moderate to high risk of developing it. The trial will compare GDC-8264 to a placebo (a treatment that does not contain the active medication) in participants who are having specific types of non-emergency heart surgery that require a heart-lung machine to support their heart and lungs during the procedure.

To be eligible for this study, participants should be at least 18 years old and scheduled for certain types of heart surgeries, like coronary artery bypass grafting or valve replacements. They should also have at least one risk factor for kidney injury, such as being over 70 years old, having diabetes, or having a history of chronic kidney disease. Participants will receive either the study drug or a placebo, and they will be monitored closely for 90 days after their surgery to see how their kidneys are functioning. This trial is currently recruiting participants, and it provides a chance to contribute to important research that could help improve care for patients undergoing heart surgery.

Gender

ALL

Eligibility criteria

• 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 \[hemoglobin \<10 grams/deciliters (g/dL)\]
• • 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. Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
• • 5. Heart transplant
• • 6. Transcatheter valve replacements
• • 7. Hypotension or shock requiring hospital admission
• • 8. Cardiopulmonary resuscitation
• • 9. eGFR \< 20 mL/min/1.73 m\^2
• • 10. Heart failure with ejection fraction \< 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
• • 11. History of kidney transplant or only one kidney (due to donation)
• • 12. Renal agenesis, total nephrectomy, or partial nephrectomy of \> 50%