A Phase II, placebo-controlled study of the efficacy and safety of GDC-8264 in preventing CSA-AKI
Research type
Research Study
Full 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
IRAS ID
1010763
Contact name
Jenn Pangilinan
Contact email
Sponsor organisation
Genentech, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test the effectiveness of a new medicine called GDC-8264 versus placebo on patients undergoing cardiac surgery who are at moderate to high risk of CSA-AKI (cardiac surgery associated acute kidney injury) and see if it helps. This study has two parts and will enrol approximately 404 participants in total at approximately 60 sites globally. The total duration of study participation for each participant is expected to be approximately 4 months.
All individuals will be considered for this clinical trial, regardless of race, ethnicity, sex, sexual orientation, gender identity, or disability status.
Genentech, Inc. (a member of the Roche Group) is the sponsor of this study.
This study has two parts. If participants are enrolled during the first part of the study, they will have a one in two (50%) chance of being placed in the GDC-8264 group. If participants are enrolled during the second part of the study, they will have a three in four (75%) chance of being placed in the GDC-8264 group.
During this study, participants will be monitored while they are hospitalised for surgery and will have up to 15 additional visits: 2-3 visits prior to hospitalisation and 12 weekly visits after they are discharged from the hospital. Some visits may be conducted by telephone. Visits may last 2-4 hours.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0853
Date of REC Opinion
30 Dec 2024
REC opinion
Further Information Favourable Opinion