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)

March 12, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast University Hospital
      • Townsville, Queensland, Australia, 4810
        • Townsville Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Belgium
      • Genk, Belgium, 3600
        • ZOL Genk campus Sint Jan
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • Hôpital de la Citadelle
  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
  • Czechia
      • Prague, Czechia, 12808
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 150 06
        • Fakultni nemocnice v Motole
  • France
      • Angers, France, 49933
        • CHU Angers
      • Paris, France, 75013
        • APHP - Hôpital de la Pitié Salpétrière
      • Reims, France, 51092
        • CHU de Reims
  • Germany
      • Dresden, Germany, 01307
        • Herzzentrum Dresden GmbH Universitatsklinikum
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3248
        • Waikato Hospital
  • South Korea
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System - PPDS
      • Seoul, South Korea, 06351
        • Samsung Medical Center - PPDS
  • Spain
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia - PPDS
      • Madrid, Spain, 28006
        • Hospital Universitario De La Princesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • California
      • Stanford, California, United States, 94305-2200
        • University of Stanford Medical Center
    • Florida
      • Tampa, Florida, United States, 33612-4745
        • James A Haley Veteran Affairs Medical Center - NAVREF - PPDS
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • John Hopkins Hospital
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Baystate Cardiac Surgery
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - PPDS
    • Nebraska
      • Lincoln, Nebraska, United States, 68526-9437
        • CHI Health Nebraska Heart
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390-7202
        • University of Texas Southwestern Medical Center
    • Virginia
      • Richmond, Virginia, United States, 99999
        • Richmond VA Medical Center NAVREF PPDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: GDC-8264
Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1.
Drug: GDC-8264
GDC-8264 will be administered as per pre-defined regimen.
Other Names:
  • RO7288817
Placebo Comparator: Part 1: Placebo
Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
Drug: Placebo
Placebo will be administered as per pre-defined regimen.
Experimental: Part 2: GDC-8264
Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2.
Drug: GDC-8264
GDC-8264 will be administered as per pre-defined regimen.
Other Names:
  • RO7288817
Placebo Comparator: Part 2: Placebo
Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
Drug: Placebo
Placebo will be administered as per pre-defined regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants who Develop MAKE90
Time Frame: From Day 0 (day of surgery) up to Day 90 post-surgery
From Day 0 (day of surgery) up to Day 90 post-surgery
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Day 90 post surgery
Up to Day 90 post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants who Develop AKI
Time Frame: From Day 0 (day of surgery) up to Day 7 post surgery
From Day 0 (day of surgery) up to Day 7 post surgery
Number of Participants With New or Worsened Chronic Kidney Disease (CKD)
Time Frame: Baseline up to Day 90 post surgery
Baseline up to Day 90 post surgery
Percentage of Participants who Develop MAKE30 and MAKE60
Time Frame: From Day 0 (day of surgery) to Day 30, Day 60 post surgery
From Day 0 (day of surgery) to Day 30, Day 60 post surgery
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline up to Days 30, 60 and 90 post surgery
Baseline up to Days 30, 60 and 90 post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Actual)

March 3, 2026

Study Completion (Actual)

March 3, 2026

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC45428
  • 2024-513125-23-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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