Evaluating GDC-8264 for preventing kidney injury after heart surgery
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events
This study is testing if a new drug called GDC-8264 can help prevent kidney problems in patients at risk after heart surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 404 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 11 sites (New Haven, Connecticut and 10 other locations) |
| Trial ID | NCT06602453 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients over 70 years old or those with specific risk factors for AKI undergoing certain types of cardiac surgery.
Not a fit: Patients with stable kidney function and no recent episodes of AKI may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of kidney injury and related complications in patients undergoing cardiac surgery.
How similar studies have performed: Other studies have explored similar interventions for preventing AKI, but the specific approach with GDC-8264 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut and 10 other locations
- 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)
- Gold Coast University Hospital — Southport, Queensland, Australia (Recruiting)
- Hopital de la Citadelle — Liege, Belgium (Recruiting)
- Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)
- C.H. Regional Reina Sofia - PPDS — Cordoba, Spain (Recruiting)
- Hospital Universitario de La Princesa — Madrid, Spain (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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.