Acute Kidney Injury
Conditions
Brief 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.
Interventions
DRUGGDC-8264
GDC-8264 will be administered as per pre-defined regimen.
DRUGPlacebo
Placebo will be administered as per pre-defined regimen.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Develop MAKE90 | From Day 0 (day of surgery) up to Day 90 post-surgery |
| Number of Participants With Adverse Events (AEs) | Up to Day 90 post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Develop AKI | From Day 0 (day of surgery) up to Day 7 post surgery |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline up to Days 30, 60 and 90 post surgery |
| Number of Participants With New or Worsened Chronic Kidney Disease (CKD) | Baseline up to Day 90 post surgery |
| Percentage of Participants who Develop MAKE30 and MAKE60 | From Day 0 (day of surgery) to Day 30, Day 60 post surgery |
Countries
Australia, Belgium, Canada, Czechia, France, Germany, Netherlands, New Zealand, South Korea, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed