HSK39297: HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.
Placebo: Placebo, once a day; treatment period; 48-weeks fixed dose.
Study summary
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. Female and male patients above 18 years of age.
3. 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
4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
5. 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
6. 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:
1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
2. All transplanted patients (any organ, including bone marrow).
3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
4. 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.
5. Pregnant or nursing (lactating) women.
6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
Primary outcome measure(s)
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks — From week 1 to week 36
Annualized total estimated Glomerular Filtration Rate slope over 48 weeks — From week 1 to week 48
Trial sites (9)
Facility
City
Region
Status
Huangshan City People's Hospital
Huangshan City
Anhui
Recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu
Anhui
Recruiting
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
Zhanjiang Central Hospital
Zhanjiang
Guangdong
Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
The Second Hospital of Jilin University
Changchun
Jilin
Recruiting
Linyi City People Hospital
Linyi
Shandong
Recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
Xijing Hospital
Xi’an
Shanxi
Recruiting
More Haisco Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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