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)

Phase 2

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Drug: Placebo; Drug: GDC-8264

• Registration Number: NCT06602453
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2025-01-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2027-11-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 404

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 2: Placebo	Placebo	Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
Part 1: GDC-8264	GDC-8264	Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1.
Part 1: Placebo	Placebo	Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
Part 2: GDC-8264	GDC-8264	Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Yale School of Medicine Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

CHI Health Nebraska Heart; 🇺🇸 Lincoln, Nebraska, United States

James A Haley Veteran Affairs Medical Center - NAVREF - PPDS; 🇺🇸 Tampa, Florida, United States

Baystate Cardiac Surgery; 🇺🇸 Springfield, Massachusetts, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Gold Coast University Hospital; 🇦🇺 Southport, Queensland, Australia

Hopital de la Citadelle; 🇧🇪 Liege, Belgium

Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

C.H. Regional Reina Sofia - PPDS; 🇪🇸 Cordoba, Spain