Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated January 13, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-07; most recent amendment 2025-01-09.
Status change: Not Yet Recruiting → Recruiting 2025-01-09
Trial Details
NCT Number NCT06632613
Lead Sponsor EnnovaBio
Conditions Cardiac Surgery Associated - Acute Kidney Injury
Enrollment 200 participants
Start Date 2024-11-05
Primary Completion 2026-02 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-01-13