Phase 2b Study of AZD2373 to Evaluate Safety and Effectiveness for APOL1-Mediated Kidney Disease in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the efficacy and safety of AZD2373 in adults aged 18 to 70 years with APOL1-Mediated Kidney Disease AMKD who have high-risk APOL1 genotypes G1 and G2. The study aims to determine if AZD2373 reduces urine albumin-to-creatinine ratio UACR more than a placebo by Week 30. This Phase 2b trial involves participants with elevated UACR and adequate kidney function, excluding those on dialysis or with other organ transplants. The study consists of two parts. Part A randomizes participants equally to receive weekly subcutaneous injections of either 50 mg AZD2373, 150 mg AZD2373, or placebo. Part B randomizes participants in a 41 ratio to receive every-other-week injections of 150 mg AZD2373 or placebo, starting after Part A enrollment completes. Participants remain on treatment for a minimum of 30 weeks. After this period, they may enter an open-label extension study. Participants will have regular assessments throughout the study, including urine and blood tests to measure UACR, urine protein-to-creatinine ratio, kidney function eGFR, drug levels, and antibody development. Safety monitoring includes tracking adverse events during treatment and for 12 weeks afterward. These evaluations help assess how the study drug affects kidney disease markers and participant health over the treatment period.

Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease