Phase
Condition
Glomerulonephritis
Treatment
Placebo
HSK39297 50mgBID
HSK39297 200mgQD
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must have signed and dated an IRB/IEC approved written informed consentform.Subjects must be willing and able to comply with scheduled visits, treatmentschedule, 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 bodymass 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 performedwithin 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-EPIformula 2021) ≥30 mL/min per 1.73 m2.
Exclusion
Exclusion Criteria:
Use of other investigational drugs at the time of enrollment, or within 5 half-livesof 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 carcinomaof the skin or in-situ cervical cancer), treated or untreated, within the past 5years, 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 subjectin case of participation in the study.
Pregnant or nursing (lactating) women.
Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
Study Design
Connect with a study center
Peking University First Hospital
Beijing, Beijing 100034
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
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