A Phase 2 interventional study of ENN0403 capsules, low dose and ENN0403 capsules, high dose in Cardiac Surgery Associated - Acute Kidney Injury, sponsored by EnnovaBio. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by EnnovaBio · Phase 2, Interventional, and Prevention
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →EnnovaBio is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ENN0403 capsules, low dose
Drug: ENN0403 capsules, high dose
Drug: Placebo
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 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 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.
Incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: 30 days
Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine and/or Urine Output per KDIGO definition
Time frame: 5 days
Percentage of subjects developing AKI in different AKI stages based on Serum Creatinine per KDIGO definition
Time frame: 5 days
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
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
Length of stay in the intensive care unit (ICU) and hospital
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
EnnovaBio