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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) | Clinical Trials | Clareo Health

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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)

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

NCT06602453•Genentech, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (34)

University of Stanford Medical Center

Stanford, California, United States

James A Haley Veteran Affairs Medical Center - NAVREF - PPDS

Tampa, Florida, United States

John Hopkins Hospital

Lutherville, Maryland, United States

Baystate Cardiac Surgery

Springfield, Massachusetts, United States

Mayo Clinic - PPDS

Rochester, Minnesota, United States

CHI Health Nebraska Heart

Lincoln, Nebraska, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Richmond VA Medical Center NAVREF PPDS

Richmond, Virginia, United States

Gold Coast University Hospital

Southport, Queensland, Australia

Key Dates

Start Date

January 17, 2025

Primary Completion Date

March 3, 2026

Completion Date

March 3, 2026

Last Updated

March 16, 2026

Enrollment

ACTUAL participants

Conditions

Acute Kidney Injury

Interventions

GDC-8264

DRUG

Placebo

DRUG

UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events

NCT05806645

Acute Kidney Injury

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RECRUITINGNA

Effects of Creatine Supplementation on Cognitive Measures and Markers of Acute Kidney Injury After Exercise in the Heat

NCT07472426

Acute Kidney InjuryExertional Heat Illness

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

UPTAKE: Using Personalized Risk and Digital Tools to Guide Transitions Following Acute Kidney Events

Effects of Creatine Supplementation on Cognitive Measures and Markers of Acute Kidney Injury After Exercise in the Heat

WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity CRRT in Critically Ill Patients

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery