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A Study to Understand the ability and safety of GDC-8264 in Preventing kidney Injury and Major Adverse Kidney Events following Heart Surgery
EU CTIS ID: 2024-513125-23-00
What this study is testing
To evaluate the efficacy of GDC-8264 compared with placebo with respect to proportion of patients who develop major adverse kidney events at 90 days after surgery (MAKE90) To evaluate the safety of GDC-8264 compared with placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 40 years at time of signing Informed Consent Form
- One of the listed 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), or mitral valve repair (MVr) - Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, or AVR+MVr Tricuspid annuloplasty at the time of mitral valve surgery, if deemed necessary by the investigator, would not preclude the patient from participating in this study
- At least one or at least two of the following AKI risk factors Age > 70 years A history of CKD with eGFR < 60 mL/min/1.73m2 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 g/dL)
- Stable kidney function as determined by the investigator with no known episodes of AKI within 2 weeks of screening
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
You likely can't join 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 (patent foramen ovale and bicuspid aortic valve are not exclusions)
- Heart transplant
- Hypotension or shock requiring hospital admission
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Korea, Republic of
- New Zealand
- Australia
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Korea, Republic of; New Zealand; Australia; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.