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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 - Hopital de la Pitie Salpetriere
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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