drugset / Trial / NCT06632613

Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery

NCT06632613 ↗

Phase 2 Recruiting 200 enrolled EnnovaBio
RandomizedParallel-groupTriple-blindPrevention

Summary

The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.

Timeline

Start
2024-11-05
Primary completion
2026-02
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ENN0403 Unknown — Oral

Indications