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

Inclusion criteria

• Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
• Female and male patients above 18 years of age.
• Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2
• Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
• 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
• Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.For patients with eGFR* 20 to <30ml/min/1.73m2, a qualifying biopsy performed in two years.

Exclusion criteria

• Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
• All transplanted patients (any organ, including bone marrow).
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
• Pregnant or nursing (lactating) women.
• Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.