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

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 5, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
Cardiac Surgery Associated - Acute Kidney Injury
Interventions
DRUG

ENN0403 capsules, low dose

ENN0403 capsules will be orally administered once a day for 5 consecutive days at low dose based on the standard treatment after cardiac surgery. If the subject is unable to swallow the investigational product autonomously, the capsules will be administrated through a nasogastric tube/oral gastric tube.

DRUG

ENN0403 capsules, high dose

ENN0403 capsules will be orally administered once a day for 5 consecutive days at high dose based on the standard treatment after cardiac surgery. If the subject is unable to swallow the investigational product autonomously, the placebo capsules will be administrated through a nasogastric tube/oral gastric tube.

DRUG

Placebo

Placebo capsules will be orally administered once a day for 5 consecutive days based on the standard treatment after cardiac surgery. If the subject is unable to swallow the investigational product autonomously, the capsules will be administrated through a nasogastric tube/oral gastric tube.

Trial Locations (1)

Unknown

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EnnovaBio

INDUSTRY

NCT06632613 - Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery | Biotech Hunter | Biotech Hunter