A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated … (NCT06602453) | Clinical Trial Compass
TerminatedPhase 2
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: Unlikely to demonstrate a statistically significant clinical benefit
United States, Australia, Belgium67 participantsStarted 2025-01-17
Plain-language 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 developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial for GDC-8264 was terminated early — do you know why it was stopped, and does that affect whether this drug might still be a viable option for me?
2Since this was a Phase 2 trial that didn't complete, what do we actually know so far about whether GDC-8264 is safe and effective at preventing acute kidney injury after cardiac surgery?
3Given that this study was measuring major adverse kidney events over 90 days, are there other completed trials or standard-of-care approaches that target the same outcome that might be worth considering instead?
4If this trial is no longer recruiting because it was terminated, are there any similar active studies investigating kidney protection during cardiac surgery that I might be eligible to discuss with you?
5How does the termination of this trial change your recommendation for how we should approach protecting my kidneys if I need cardiac surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants who Develop MAKE90
Timeframe: From Day 0 (day of surgery) up to Day 90 post-surgery