Trials / Terminated
TerminatedNCT06602453
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 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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GDC-8264 | GDC-8264 will be administered as per pre-defined regimen. |
| DRUG | Placebo | Placebo will be administered as per pre-defined regimen. |
Timeline
- Start date
- 2025-01-17
- Primary completion
- 2026-03-03
- Completion
- 2026-03-03
- First posted
- 2024-09-19
- Last updated
- 2026-03-16
Locations
34 sites across 12 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Netherlands, New Zealand, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06602453. Inclusion in this directory is not an endorsement.