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

NCT ID: NCT06632613

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2026-03-31

Brief 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.

Conditions

Cardiac Surgery Associated - Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

ENN0403 capsules, low dose

Group Type: EXPERIMENTAL

ENN0403 capsules, low dose

Intervention Type: DRUG

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, high dose

Group Type: EXPERIMENTAL

ENN0403 capsules, high dose

Intervention Type: DRUG

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.

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and comply with the study requirements and able to provide written informed consent;

2. Age ≥18 and ≤85 years;

3. Male subjects (and their fertile female spouses/partners) do not have pregnancy plans during the screening period and within 3 months after the last dose, voluntarily take highly effective contraception, and must not donate sperm or ova. Only non-fertile women will be enrolled, and female subjects who meet the following criteria are not considered fertile: Postmenopausal status has been achieved, normal menstruation has stopped for at least 12 consecutive months with an FSH >30 IU/L in the absence of other pathophysiological causes, or there is a medical record showing hysterectomy \ bilateral tubal resection and/or bilateral ovariectomy.

4. Subjects must be scheduled for cardiac surgery requring cardiopulmonary bypass: Coronary artery bypass grafting (CABG) and/or heart valve surgery and/or aortic root, ascending aorta and aortic arch surgery;

5. Subjects have the risk of developing AKI with at least one of the following criteria: coronary artery bypass grafting combined with one or more heart valves surgery plus at least one risk factor for AKI; Multiple heart valves surgery plus at least one AKI risk factor; Coronary artery bypass grafting or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection) plus at least one risk factor for AKI; Coronary artery bypass grafting alone or single heart valve surgery plus at least 2 risk factors for AKI.

Exclusion Criteria

1. Receive ICD or permanent pacemaker implantation, mechanical ventilation, IABP, LVAD or other mechanical circulatory AIDS within 1 week before surgery;

2. Cardiopulmonary resuscitation is performed within 14 days prior to screening;

3. Abnormal renal function with eGFR<20 mL/min/1.73 m2 within 30 days before screening;

4. Receive renal replacement therapy or the presence of AKI within 30 days before surgery, except for transient (≤5 days) stage 1 AKI after iodized contrast agent exposure;

5. Participate in other clinical trials within the past 1 month;

6. Have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study;

7. Subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EnnovaBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyu Ma

Role: CONTACT

xiaoyu.ma@ennovabio.com

021-50821573

Other Identifiers

ENN0403-P2-CN-02

Identifier Type: -

Identifier Source: org_study_id