Acute Kidney InjuryPhase 2NCT06602453
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 2 study testing GDC-8264 in people with Acute Kidney Injury, run by Genentech, Inc. at 34 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- GDC-8264
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 34 sitesin 12 countries
- Study dates
- 17 Jan 2025to 3 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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)]
- Stable kidney function with no known episodes of AKI within 2 weeks of screening
Who cannot join
- Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
- Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
- Presence of a durable left ventricular assist device
- Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
- Heart transplant
- Transcatheter valve replacements
Show all 12Show fewer
- Hypotension or shock requiring hospital admission
- Cardiopulmonary resuscitation
- eGFR < 20 mL/min/1.73 m^2
- Heart failure with ejection fraction < 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
- History of kidney transplant or only one kidney (due to donation)
- Renal agenesis, total nephrectomy, or partial nephrectomy of > 50%
Trial locations and contacts
34 sites in 12 countries.
34 sites in 12 countries
United States9 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7202
Duke University Medical Center
Durham, North Carolina, 27705
CHI Health Nebraska Heart
Lincoln, Nebraska, 68526-9437
John Hopkins Hospital
Lutherville, Maryland, 21093
Richmond VA Medical Center NAVREF PPDS
Richmond, Virginia, 99999
Mayo Clinic - PPDS
Rochester, Minnesota, 55905-0001
Baystate Cardiac Surgery
Springfield, Massachusetts, 01107
University of Stanford Medical Center
Stanford, California, 94305-2200
James A Haley Veteran Affairs Medical Center - NAVREF - PPDS
Tampa, Florida, 33612-4745
Spain4 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario de La Princesa
Madrid, 28006
Australia3 sites
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Gold Coast University Hospital
Southport, Queensland, 4215
Townsville Hospital
Townsville, Queensland, 4810
Belgium3 sites
ZOL Genk campus Sint Jan
Genk, 3600
UZ Leuven
Leuven, 3000
Hopital de la Citadelle
Liège, 4000
France3 sites
CHU Angers
Angers, 49933
APHP - Hopital de la Pitie Salpetriere
Paris, 75013
CHU de Reims
Reims, 51092
Czechia2 sites
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Fakultni nemocnice v Motole
Prague, 150 06
Germany2 sites
Herzzentrum Dresden GmbH Universitatsklinikum
Dresden, 01307
Universitätsklinikum Essen
Essen, 45147
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Waikato Hospital
Hamilton, 3248
South Korea2 sites
Severance Hospital Yonsei University Health System - PPDS
Seoul, 03722
Samsung Medical Center - PPDS
Seoul, 06351
United Kingdom2 sites
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: 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.
- Conditions
- Acute Kidney Injury
- Being tested
- GDC-8264, Placebo
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-8264Drug
Also called RO7288817
GDC-8264 will be administered as per pre-defined regimen.
PlaceboDrug
Placebo will be administered as per pre-defined regimen.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: GDC-8264 | Experimental | Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1. Receives: Drug: GDC-8264 |
| Part 1: Placebo | Placebo comparator | Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1. Receives: Drug: Placebo |
| Part 2: GDC-8264 | Experimental | Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2. Receives: Drug: GDC-8264 |
| Part 2: Placebo | Placebo comparator | Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Develop MAKE90
Measured: From Day 0 (day of surgery) up to Day 90 post-surgery
Number of Participants With Adverse Events (AEs)
Measured: Up to Day 90 post surgery
Secondary outcomes (4)
Percentage of Participants who Develop AKI
Measured: From Day 0 (day of surgery) up to Day 7 post surgery
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline up to Days 30, 60 and 90 post surgery
Number of Participants With New or Worsened Chronic Kidney Disease (CKD)
Measured: Baseline up to Day 90 post surgery
Percentage of Participants who Develop MAKE30 and MAKE60
Measured: From Day 0 (day of surgery) to Day 30, Day 60 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Jan 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Why it stopped: Unlikely to demonstrate a statistically significant clinical benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602453
- Sponsor's protocol ID
- GC45428
- Other IDs
- 2024-513125-23-00
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06602453
- Acronym / sponsor ID
- GC45428
- Conditions
- Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unlikely to demonstrate a statistically significant clinical benefit
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: GDC-8264 | Experimental | Drug: GDC-8264Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1. |
| Part 2: GDC-8264 | Experimental | Drug: GDC-8264Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 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)]
- Stable kidney function with no known episodes of AKI within 2 weeks of screening
Key exclusion criteria (12 listed)
- Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
- Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
- Presence of a durable left ventricular assist device
- Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
- Heart transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-8264Also: RO7288817GDC-8264 will be administered as per pre-defined regimen. | Drug | Part 1: GDC-8264, Part 2: GDC-8264 |
| PlaceboPlacebo will be administered as per pre-defined regimen. | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Percentage of Participants who Develop MAKE90
Time frame: 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
4 secondary outcomes
Percentage of Participants who Develop AKI
Time frame: From Day 0 (day of surgery) up to Day 7 post surgery
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline up to Days 30, 60 and 90 post surgery
Number of Participants With New or Worsened Chronic Kidney Disease (CKD)
Time frame: 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
Results and safety
The study was stopped early (reason given: Unlikely to demonstrate a statistically significant clinical benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
34 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GDC-8264 in people with Acute Kidney Injury, run by Genentech, Inc. at 34 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Spain, Australia, Belgium, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unlikely to demonstrate a statistically significant clinical benefit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Develop MAKE90 (time frame: From Day 0 (day of surgery) up to Day 90 post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.