Health TrialsbyHealthPanel

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

ConditionCardiac Surgery Associated - Acute Kidney Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEnnovaBio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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, 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.

  • 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.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: ENN0403 capsules, low doseExperimental treatment 1 intervention
Group B: ENN0403 capsules, high doseExperimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AE) and serious adverse events (SAE)

Time frame
30 days
2

Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition

Time frame
5 days

Secondary outcomes

1

Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine per KDIGO definition

Time frame
5 days
2

Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition

Time frame
3 days, 7 days
3

Major Adverse Kidney Event (MAKE) at Day 30

major adverse kidney events at 30 day (MAKE30) defined as the proportion of patients developing at least one of the following: death, need for renal replacement therapy, or ≥25% reduction in eGFR from baseline

Time frame
Day 30
4

Length of stay in the intensive care unit (ICU) and hospital

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EnnovaBio

Lead sponsor

Source ClinicalTrials.gov
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