Evaluating GDC-8264 for preventing kidney injury after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of GDC-8264 compared to a placebo in patients undergoing non-emergent cardiac surgeries who are at moderate to high risk for acute kidney injury (AKI) and major adverse kidney events (MAKE) within 90 days post-surgery. The trial is divided into two parts to comprehensively evaluate the outcomes. Participants will be monitored for kidney function and related complications following their surgical procedures.

Why it matters

Who can join: the full rules

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%

Where it's running

• Yale School of Medicine Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• James A Haley Veteran Affairs Medical Center - NAVREF - PPDS
  Tampa, Florida, United States Recruiting
• Baystate Cardiac Surgery
  Springfield, Massachusetts, United States Recruiting
• CHI Health Nebraska Heart
  Lincoln, Nebraska, United States Recruiting
• Columbia University Irving Medical Center
  New York, New York, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GC45428 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.