Phase III Study of SC0062 Capsule to Treat IgA Nephropathy with Proteinuria in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of SC0062 capsules compared to a placebo in adults with IgA nephropathy who have proteinuria and are at high risk of disease progression. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on patients who have been on stable, maximum tolerated doses of RAAS inhibitors andor SGLT2 inhibitors for at least 12 weeks before starting the trial. Participants will be randomly assigned to take either SC0062 capsules or placebo capsules once daily, alongside their regular background medications, for a treatment period of 108 weeks. Both groups will take two capsules daily during this time. The study aims to carefully monitor changes in kidney function and protein levels in urine over the treatment period. During the study, participants will undergo regular assessments including measurements of 24-hour urine protein-to-creatinine ratio at baseline and 36 weeks, as well as estimated glomerular filtration rate eGFR at baseline and 108 weeks. These evaluations help researchers monitor kidney health and disease progression. Safety will be closely observed throughout the study, which may last several years until final follow-up in 2028.

A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria