Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiac Surgery Associated - Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

Incidence of adverse events (AE) and serious adverse events (SAE)
30 days
Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition
5 days

Secondary Outcomes (4)

Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine per KDIGO definition
5 days
Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition
3 days, 7 days
Major Adverse Kidney Event (MAKE) at Day 30
Day 30
Length of stay in the intensive care unit (ICU) and hospital
30 days

Study Arms (3)

ENN0403 capsules, low dose

EXPERIMENTAL

Drug: ENN0403 capsules, low dose

ENN0403 capsules, high dose

EXPERIMENTAL

Drug: ENN0403 capsules, high dose

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

ENN0403 capsules, low doseDrug

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.

ENN0403 capsules, low dose

ENN0403 capsules, high doseDrug

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.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ability to understand and comply with the study requirements and able to provide written informed consent;
Age ≥18 and ≤85 years;

Sponsors & Collaborators

EnnovaBio
Industrylead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

Central Study Contacts

Xiaoyu Ma

CONTACT

021-50821573 xiaoyu.ma@ennovabio.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 9, 2024

Study Start

November 5, 2024

Actual (reported)

Primary Completion

February 2026

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (3)

ENN0403 capsules, low dose

ENN0403 capsules, high dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (3)

ENN0403 capsules, low dose

ENN0403 capsules, high dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations