Phase II Multicenter Study of HSK39297 Tablets for Long-Term Safety and Effectiveness in Primary IgA Nephropathy

What this Trial Is About

Researchers are evaluating the long-term safety and efficacy of HSK39297 tablets in people with primary IgA nephropathy who have completed a previous related study. This Phase II, multicenter, open-label trial focuses on patients with a stable condition and a favorable benefit-risk profile for HSK39297 treatment. The study aims to assess treatment effects over 48 weeks and includes careful monitoring of adverse events and kidney function markers. Participants will start taking HSK39297 at a dose of 200 mg once daily. After 8 to 12 weeks on this stable dose, the dose may be increased to 300 mg once daily if 24-hour urine protein excretion remains above 1 gram and no serious treatment-related adverse events have occurred. Following the treatment period, there will be a 4-week safety follow-up to monitor participants health. Throughout the study, researchers will regularly measure and monitor urine protein excretion, urine protein-to-creatinine ratio, kidney filtration rate, presence of blood in the urine, and fatigue levels using a specialized assessment tool. These evaluations occur every 12 to 24 weeks during the 48-week treatment. The study also tracks the incidence and severity of adverse events to understand the treatments safety. Participants must maintain stable background therapies and vaccinations as required.

A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy