Phase
Condition
Glomerulonephritis
Treatment
Placebo
HSK39297
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 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-EPIformula 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
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).
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
Huangshan City People's Hospital
Huangshan City, Anhui
ChinaActive - Recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
ChinaActive - Recruiting
Peking University First Hospital
Beijing, Beijing Municipality 100034
ChinaActive - Recruiting
Zhanjiang Central Hospital
Zhanjiang, Guangdong
ChinaActive - Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
ChinaActive - Recruiting
The Second Hospital of Jilin University
Changchun, Jilin
ChinaActive - Recruiting
Linyi City People Hospital
Linyi, Shandong
ChinaActive - Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
ChinaActive - Recruiting
Xijing Hospital
Xi’an, Shanxi
ChinaActive - Recruiting

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