Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

Last updated: May 27, 2026
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Glomerulonephritis

Treatment

Placebo

HSK39297

Clinical Study ID

NCT07390123
HSK39297-303
  • Ages > 18
  • All Genders

Study Summary

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  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 bodymass 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 performedwithin 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-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:

  1. Use of other investigational drugs at the time of enrollment, or within 5 half-livesof 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 carcinomaof 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 subjectin case of participation in the study.

  5. Pregnant or nursing (lactating) women.

  6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.

Study Design

Total Participants: 370
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 07, 2026
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • Huangshan City People's Hospital

    Huangshan City, Anhui
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality 100034
    China

    Active - Recruiting

  • Zhanjiang Central Hospital

    Zhanjiang, Guangdong
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Active - Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

  • Linyi City People Hospital

    Linyi, Shandong
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality
    China

    Active - Recruiting

  • Xijing Hospital

    Xi’an, Shanxi
    China

    Active - Recruiting

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