Evaluating ENN0403 for preventing kidney injury after heart surgery

A Phase 2 Clinical Study Evaluating the Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery Requiring Cardiopulmonary Bypass

This study is testing if a new drug called ENN0403 can help prevent kidney injury in patients who are at high risk after heart surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: EnnovaBio (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06632613 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety and efficacy of ENN0403 in patients who are at high risk for acute kidney injury (AKI) following elective cardiac surgery that requires cardiopulmonary bypass. The study is divided into two stages: the first stage focuses on evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENN0403, while the second stage aims to determine its effectiveness in preventing and treating AKI through multiple administrations. Participants will receive either ENN0403 in low or high doses or a placebo to compare outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 who are scheduled for elective cardiac surgery requiring cardiopulmonary bypass and are at high risk for AKI.

Not a fit: Patients who are not undergoing elective cardiac surgery or those with conditions that preclude participation, such as certain fertility issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of acute kidney injury in patients undergoing high-risk cardiac surgeries.

How similar studies have performed: While there have been studies on kidney injury prevention in cardiac surgery, the specific approach using ENN0403 is novel and has not been extensively tested.

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.

Where this trial is running

Shanghai

• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyu Ma

Conditions Cardiac Surgery Associated - Acute Kidney Injury