Phase 2b Study of Isuzinaxib to Assess Safety and Effectiveness in Adults With Diabetic Kidney Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of Isuzinaxib compared to a placebo in adults with diabetic kidney disease DKD. This Phase 2b study is randomized, double-blind, placebo-controlled, and dose-ranging, aiming to better understand how Isuzinaxib works in this patient population. The study is sponsored by Aptabio Therapeutics, Inc. and focuses on managing DKD through medication evaluation. Participants will be randomly assigned to one of three groups to receive either 400 mg of Isuzinaxib, 200 mg of Isuzinaxib, or a placebo. All treatments are taken orally once daily. The study is multicenter and includes dose-ranging to assess different levels of Isuzinaxib. The treatment period lasts 24 weeks, during which participants will be closely monitored. During the study, participants will undergo regular assessments including measurements of urine albumin-creatinine ratio UACR over 24 weeks, estimated glomerular filtration rate eGFR, and safety evaluations such as adverse event monitoring and pharmacokinetic analyses. Participants are expected to comply with study procedures, dietary management for diabetes, and use birth control if applicable. The total duration involves screening and the 24-week treatment period with safety and efficacy follow-up.

Efficacy and Safety Study of Isuzinaxib in Subjects With DKD