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)

NCT06602453 ↗

Phase 2 Terminated 67 enrolled Genentech, Inc.
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

EvaluationDrugModalityDoseRoute
Subject FLIZASERTIB Small molecule — —

Indications