Actively Recruiting
Study of ENN0403 Capsules for Patients at High Risk of Acute Kidney Injury After Elective Cardiac Surgery with Cardiopulmonary Bypass
Led by EnnovaBio · Updated on 2025-01-13
200
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ENN0403 in patients at high risk for acute kidney injury (AKI) following elective cardiac surgery that requires cardiopulmonary bypass. This is a phase 2 clinical study conducted in two stages. The first stage focuses on assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ENN0403. The second stage evaluates the efficacy, safety, PK, and PD of multiple doses of ENN0403 to prevent and treat AKI in these patients. Participants will receive either low-dose ENN0403 capsules, high-dose ENN0403 capsules, or placebo capsules orally once a day for five consecutive days after cardiac surgery. If a participant cannot swallow capsules, the medication will be given through a nasogastric or oral gastric tube. The treatment follows standard care after surgery, and the study compares these different dosing regimens to monitor outcomes. Throughout the study, researchers will monitor the incidence of adverse events and serious adverse events over 30 days. They will also measure the percentage of participants developing AKI within 5 days, using serum creatinine and urine output according to KDIGO definitions. Participants will be carefully assessed for safety, kidney function, and treatment effects during and after the intervention period to understand the impact of ENN0403 on AKI risk after cardiac surgery.
CONDITIONS
Official 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 comply with study requirements and provide written informed consent
- Age 18 to 85 years
- Male subjects and their fertile female partners must not plan pregnancy during screening and 3 months after last dose; only non-fertile women are eligible
- Scheduled for cardiac surgery requiring cardiopulmonary bypass, including coronary artery bypass grafting and/or heart valve surgery, aortic root, ascending aorta, or aortic arch surgery
- At risk for AKI based on specific surgery combinations and risk factors as defined in the protocol
You will not qualify if you...
- Received ICD or permanent pacemaker implantation, mechanical ventilation, intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or other mechanical circulatory aids within 1 week before surgery
- Cardiopulmonary resuscitation within 14 days prior to screening
- Abnormal renal 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 agent exposure
- Participation in other clinical trials within the past month
- Known allergy to investigational drug or any constituents used in the study
- Intractable hypotension, severe hypoxemia, or other surgical emergencies
AI-Screening
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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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