Evaluating Safety and Effectiveness of STL303 Capsules Compared to Placebo in Adults with Primary Immunoglobulin A Nephropathy A Multicenter, Randomized, Double-Blind Phase 2 Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of STL303 capsules in adults diagnosed with primary Immunoglobulin A nephropathy IgAN in this multicenter, randomized, double-blind, placebo-controlled Phase 2 study. The trial aims to assess the optimal dose of STL303 by comparing two different doses of the drug against a placebo in patients who continue their background therapy. Approximately 15 patients will participate in this study. Participants will be randomly assigned to one of three groups STL303 dose level 1, STL303 dose level 2, or placebo. Each participant will take the assigned capsules orally once daily. The study includes a treatment period lasting 180 days, during which the drug or placebo is administered, followed by an end-of-study safety follow-up on Day 210. During the study, participants will undergo multiple assessments including monitoring of adverse events, urine protein-to-creatinine ratio, urine albumin-to-creatinine ratio, blood creatinine levels, and kidney function eGFR slope. Blood and urine samples will be collected at scheduled visits throughout the 180-day treatment period. Safety will be closely monitored with clinic visits on Days 7, 14, 30, 45, 60, 90, 135, 180, and a final follow-up visit on Day 210 to evaluate treatment emergent adverse events and other safety parameters.

Safety and Efficacy of STL303 In Patients With Primary Immunoglobulin A (IgA) Nephropathy