Phase 2 Study of ENN0403 Capsules to Prevent Acute Kidney Injury in Adults Undergoing Elective Cardiac Surgery with Cardiopulmonary Bypass

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 ENN0403s 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.

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