Actively Recruiting
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
Led by EnnovaBio · Updated on 2025-01-13
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ENN0403 to evaluate its safety, tolerability, and effects in patients at high risk of acute kidney injury (AKI) after elective cardiac surgery requiring cardiopulmonary bypass. The study has two stages: the first focuses on safety and drug behavior, while the second assesses ENN0403's ability to prevent and treat AKI after multiple doses. This phase 2 trial aims to understand how this treatment works in this specific patient group. Participants will be randomly assigned to receive one of three treatments: low-dose ENN0403 capsules, high-dose ENN0403 capsules, or placebo capsules. These treatments are given orally once daily for five consecutive days following cardiac surgery. If participants cannot swallow capsules, the medication may be given through a tube. The study compares the different doses and placebo to monitor safety and effectiveness. Throughout the study, researchers will monitor participants for side effects and the development of AKI based on kidney function tests and urine output over several days. They will also assess serious kidney-related events, intensive care and hospital stays, and other safety measures up to 30 days. Participants will undergo regular evaluations, including lab tests and clinical assessments, to track treatment effects and safety during the study period.
CONDITIONS
Brief Title
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and follow study requirements and provide written informed consent
- Age 18 to 85 years
- Male subjects (and fertile female partners) must use effective contraception and avoid sperm or ova donation during screening and 3 months post-treatment; only non-fertile women are eligible
- Scheduled for cardiac surgery requiring cardiopulmonary bypass including CABG, heart valve surgery, or aortic surgery
- At risk of developing AKI based on specific surgical combinations and risk factors
You will not qualify if you...
- Received ICD, pacemaker implantation, mechanical ventilation, or mechanical circulatory support within 1 week before surgery
- Cardiopulmonary resuscitation within 14 days prior to screening
- Abnormal kidney function with eGFR less than 20 mL/min/1.73 m2 within 30 days before screening
- Received renal replacement therapy or had AKI within 30 days before surgery, except transient stage 1 AKI after contrast exposure
- Participated in another clinical trial within the past month
- Known allergy to the investigational drug or any study components
- Intractable low blood pressure, severe low oxygen, or other emergencies during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 days
Participants receive ENN0403 capsules or placebo orally once a day for 5 consecutive days after cardiac surgery. Capsules may be administered via a nasogastric or oral gastric tube if needed.
Daily visits or assessments during treatment
Duration - 30 days
Participants are monitored for safety and kidney function for up to 30 days after treatment to assess adverse events and kidney outcomes.
Visits or assessments up to 30 days post-treatment
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
Xiaoyu Ma
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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