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)

NCT06602453 | Terminated Phase 2 FDA Drug

• 2 other identifiers: GC454282024-513125-23-00
• Study Type: interventional
• Target: 67
• Locations: 12 countries
• Sites: 34

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants who Develop MAKE90

  From Day 0 (day of surgery) up to Day 90 post-surgery

• Number of Participants With Adverse Events (AEs)

  Up to Day 90 post surgery

Secondary Outcomes (4)

• Percentage of Participants who Develop AKI

  From Day 0 (day of surgery) up to Day 7 post surgery

• Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

  Baseline up to Days 30, 60 and 90 post surgery

• Number of Participants With New or Worsened Chronic Kidney Disease (CKD)

  Baseline up to Day 90 post surgery

• Percentage of Participants who Develop MAKE30 and MAKE60

  From Day 0 (day of surgery) to Day 30, Day 60 post surgery

Study Arms (4)

Part 1: GDC-8264

EXPERIMENTAL

Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1.

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.

Drug: Placebo

Part 2: GDC-8264

EXPERIMENTAL

Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2.

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.

Drug: Placebo

Interventions

GDC-8264 DRUG

GDC-8264 will be administered as per pre-defined regimen.

Also known as: RO7288817

Part 1: GDC-8264; Part 2: GDC-8264

Placebo DRUG

Placebo will be administered as per pre-defined regimen.

Part 1: Placebo; Part 2: Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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%

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (34)

University of Stanford Medical Center

Stanford, California, 94305-2200, United States

Location

James A Haley Veteran Affairs Medical Center - NAVREF - PPDS

Tampa, Florida, 33612-4745, United States

Location

John Hopkins Hospital

Lutherville, Maryland, 21093, United States

Location

Baystate Cardiac Surgery

Springfield, Massachusetts, 01107, United States

Location

Mayo Clinic - PPDS

Rochester, Minnesota, 55905-0001, United States

Location

CHI Health Nebraska Heart

Lincoln, Nebraska, 68526-9437, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-7202, United States

Location

Richmond VA Medical Center NAVREF PPDS

Richmond, Virginia, 99999, United States

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Townsville Hospital

Townsville, Queensland, 4810, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

ZOL Genk campus Sint Jan

Genk, 3600, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Hopital de la Citadelle

Liège, 4000, Belgium

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

CHU Angers

Angers, 49933, France

Location

APHP - Hopital de la Pitie Salpetriere

Paris, 75013, France

Location

CHU de Reims

Reims, 51092, France

Location

Herzzentrum Dresden GmbH Universitatsklinikum

Dresden, 01307, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, 3248, New Zealand

Location

Severance Hospital Yonsei University Health System - PPDS

Seoul, 03722, South Korea

Location

Samsung Medical Center - PPDS

Seoul, 06351, South Korea

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

C.H. Regional Reina Sofia - PPDS

Córdoba, 14004, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: January 17, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); ES (4); AU (3); US (9); CA (1); FR (3); BE (3); CZ (2); NL (1); NZ (2); DE (2); KR (2)