Actively Recruiting
Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery
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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
Xiaoyu Ma
CONTACT
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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