Tests HSK39297 tablets against placebo in people with IgA nephropathy
Tests HSK39297 tablets against placebo in adults with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
Key facts
- Where
- Beijing, Changchun, Changsha, Huangshan City, Linyi, Shanghai, Wuhu, Xi'an, and Zhanjiang, ChinaSee the 9 sites
- Phase
- Phase 3
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- The Second Hospital of Jilin UniversityChangchun, ChinaTaking people
- Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- Huangshan City People's HospitalHuangshan City, ChinaTaking people
- Linyi City People HospitalLinyi, ChinaTaking people
- Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking people
- the Second Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaTaking people
- Xijing hospitalXi'an, ChinaTaking people
- Zhanjiang Central HospitalZhanjiang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07390123
- Record updated
- 28 May 2026
- Original description
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgANRead full original descriptionShow less
A Randomized, Double-blind, and Placebo-controlled Parallel Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients With Primary IgAN
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
Inclusion: 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: Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer; Plasma donation (≥ 400mL) within 12 weeks prior to first dosing; 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; All transplanted patients (any organ, including bone marrow); Pregnant or nursing (lactating) women.