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)
NCT ID: NCT06602453
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
404 participants
INTERVENTIONAL
2025-01-17
2027-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part 1: GDC-8264
Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1.
GDC-8264
GDC-8264 will be administered as per pre-defined regimen.
Part 1: Placebo
Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
Placebo
Placebo will be administered as per pre-defined regimen.
Part 2: GDC-8264
Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2.
GDC-8264
GDC-8264 will be administered as per pre-defined regimen.
Part 2: Placebo
Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
Placebo
Placebo will be administered as per pre-defined regimen.
Interventions
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GDC-8264
GDC-8264 will be administered as per pre-defined regimen.
Placebo
Placebo will be administered as per pre-defined regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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%
40 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of Stanford Medical Center
Stanford, California, United States
Yale School of Medicine Yale New Haven Hospital
New Haven, Connecticut, 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
Columbia University Irving Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Atrium Health Wake Forest University School of Medicine - PPDS
Winston-Salem, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Richmond VA Medical Center NAVREF PPDS
Richmond, Virginia, United States
Aurora St Lukes Medical Center
Milwaukee, Wisconsin, United States
Gold Coast University Hospital
Southport, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
ZOL Genk campus Sint Jan
Genk, , Belgium
UZ Leuven
Leuven, , Belgium
Hopital de la Citadelle
Liège, , Belgium
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
CHU Angers
Angers, , France
APHP - Hopital de la Pitie Salpetriere
Paris, , France
CHU de Reims
Reims, , France
Herzzentrum Dresden GmbH Universitatsklinikum
Dresden, , Germany
Universitätsklinikum Essen
Essen, , Germany
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Severance Hospital Yonsei University Health System - PPDS
Seoul, , South Korea
Samsung Medical Center - PPDS
Seoul, , South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: GC45428 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2024-513125-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
GC45428
Identifier Type: -
Identifier Source: org_study_id
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