Haisco(SZ:002653) Xin Lang Cai Jing·2026-01-29 04:40Core Viewpoint - The clinical trial for HSK39297 tablets, aimed at treating primary IgA nephropathy, has been initiated, focusing on its efficacy and safety over a 48-week period [1][2]. Group 1: Clinical Trial Details - The trial is a multicenter, randomized, double-blind, placebo-controlled Phase III study with a registration number CTR20260278, first published on January 29, 2026 [1]. - The primary objective is to evaluate the effectiveness of HSK39297 in reducing proteinuria after 36 weeks and delaying the decline in renal function after 48 weeks in patients with primary IgA nephropathy [1]. - Secondary objectives include assessing the drug's effectiveness in delaying renal function decline and reducing proteinuria, as well as its impact on patients' quality of life and disease progression [1]. Group 2: Trial Endpoints - Primary endpoints include the ratio of 24-hour urine protein creatinine ratio (24h-UPCR) compared to baseline after 36 weeks and the annualized total slope of estimated glomerular filtration rate (eGFR) after 48 weeks [2]. - Secondary endpoints consist of various measures of eGFR and proteinuria at multiple time points (36, 48, and 104 weeks), as well as changes in plasma concentration of HSK39297 and adverse events during the study [2]. Group 3: Trial Status - The trial is currently ongoing and has not yet recruited participants, with a target enrollment of 370 individuals [3].