Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN

Last updated: October 30, 2024
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Glomerulonephritis

Treatment

Placebo

HSK39297 50mgBID

HSK39297 200mgQD

Clinical Study ID

NCT06670352
HSK39297-202
  • 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 five years.

  5. Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.

  6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPIformula 2021) ≥30 mL/min per 1.73 m2.

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), treated or untreated, within the past 5years, regardless of whether there is evidence of local recurrence or metastases.

  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: 80
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 12, 2024
Estimated Completion Date:
March 15, 2026

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

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