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

NCT06632613 | Recruiting Phase 2

• 1 other identifier: ENN0403-P2-CN-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

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 dose 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, low dose

ENN0403 capsules, high dose 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.

ENN0403 capsules, high dose

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• 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.
• 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;
• 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.

You may not qualify if:

• Receive ICD or permanent pacemaker implantation, mechanical ventilation, IABP, LVAD or other mechanical circulatory AIDS within 1 week before surgery;
• Cardiopulmonary resuscitation is performed within 14 days prior to screening;
• Abnormal renal function with eGFR\<20 mL/min/1.73 m2 within 30 days before screening;
• 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;
• Participate in other clinical trials within the past 1 month;
• Have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study;
• Subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.

Sponsors & Collaborators

• EnnovaBio: lead

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
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)