Phase 3 Study of HSK39297 Tablets to Treat Adults With Primary IgA Nephropathy Randomized, Double-blind, Placebo-controlled Parallel Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of HSK39297 tablets in adults with primary IgA nephropathy IgAN, a kidney condition. This is a Phase 3 study sponsored by Haisco Pharmaceutical Group Co., Ltd. The trial aims to understand how HSK39297 impacts kidney function and protein levels in urine compared to placebo in patients diagnosed with IgAN confirmed by biopsy within the last ten years. Participants will be randomly assigned to receive either HSK39297 at a dose of 200 mg once daily or a placebo, both given for a fixed treatment period of 48 weeks. The study is double-blind, meaning neither the participants nor researchers know who receives the active drug or placebo during the trial. The primary treatment period lasts 48 weeks, during which participants take the assigned tablets daily. During the study, participants will have regular visits to monitor kidney function through urine protein to creatinine ratio measured from 24-hour urine collections and estimated glomerular filtration rate eGFR. These measures will be assessed up to 48 weeks and even up to 104 weeks for some outcomes. Safety will be monitored throughout the study period, which can last up to 108 weeks, including tracking any adverse events. Participants will be asked to comply with scheduled lab tests and visits to support thorough evaluation of the treatment effects and safety.

Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN