drugset / Trial / NCT06602453
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)
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2025-01-17
- Primary completion
- 2026-03-03
- Completion
- 2026-03-03
Outcome
Outcome not reported
Stopped: “Unlikely to demonstrate a statistically significant clinical benefit”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FLIZASERTIB | Small molecule | — | — |