GDC-8264 for Acute Kidney Injury
Trial Summary
What is the purpose of this trial?
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.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults at moderate to high risk of acute kidney injury (AKI) after cardiac surgery. Eligible participants must have stable kidney function, be over 70 or have chronic kidney disease, diabetes, COPD, weak heart pump function, or preoperative anemia. They must be scheduled for certain types of heart surgeries with cardiopulmonary bypass.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive GDC-8264 or placebo as per a pre-defined dosing regimen in Part 1
Treatment Part 2
Participants receive GDC-8264 or placebo as per a pre-defined dosing regimen in Part 2
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of MAKE at 90 days after surgery
Treatment Details
Interventions
- GDC-8264
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genentech, Inc.
Lead Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD