Status:
RECRUITING
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)
Lead Sponsor:
Genentech, Inc.
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developin...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
January 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2027
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT06602453
Start Date
January 17 2025
End Date
November 15 2027
Last Update
January 6 2026
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
University of Stanford Medical Center
Stanford, California, United States, 94305-2200
3
Yale School of Medicine Yale New Haven Hospital
New Haven, Connecticut, United States, 06519-1369
4
James A Haley Veteran Affairs Medical Center - NAVREF - PPDS
Tampa, Florida, United States, 33612-4745