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)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Acute Kidney Injury
In brief
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 developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.
Key facts
- Study ID
- NCT06602453
- Run by
- Genentech, Inc.
- People needed
- 67
- Starts
- 2025-01-17
- Expected to finish
- 2026-03-03
- Last updated by the study team
- 2026-03-16
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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%
Where it is running
- University of Stanford Medical Center — Stanford, California, United States
- James A Haley Veteran Affairs Medical Center - NAVREF - PPDS — Tampa, Florida, United States
- John Hopkins Hospital — Lutherville, Maryland, United States
- Baystate Cardiac Surgery — Springfield, Massachusetts, United States
- Mayo Clinic - PPDS — Rochester, Minnesota, United States
- CHI Health Nebraska Heart — Lincoln, Nebraska, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Richmond VA Medical Center NAVREF PPDS — Richmond, Virginia, United States
- Gold Coast University Hospital — Southport, Queensland, Australia
- Townsville Hospital — Townsville, Queensland, Australia
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia
- ZOL Genk campus Sint Jan — Genk, Belgium
- UZ Leuven — Leuven, Belgium
- Hopital de la Citadelle — Liège, Belgium
- Saint John Regional Hospital — Saint John, New Brunswick, Canada
- Vseobecna fakultni nemocnice v Praze — Prague, Czechia
- Fakultni nemocnice v Motole — Prague, Czechia
- CHU Angers — Angers, France
- APHP - Hopital de la Pitie Salpetriere — Paris, France
- CHU de Reims — Reims, France
- Herzzentrum Dresden GmbH Universitatsklinikum — Dresden, Germany
- Universitätsklinikum Essen — Essen, Germany
- Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
- Auckland City Hospital — Auckland, New Zealand
Full record on ClinicalTrials.gov
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