Overview
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Eligibility
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 five years.
- Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
- Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.
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), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- 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.