RecruitingPhase 2NCT06670352

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

A Randomized, Double-blind, and Placebo-controlled Parallel Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients with Primary IgAN

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

80 participants

Start Date

Oct 12, 2024

Study Type

INTERVENTIONAL

Conditions

IgA Nephropathy (IgAN)

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 five years.
Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.

Exclusion Criteria6

Use of other investigational drugs at the time of enrollment, or within 5 half-lives of 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 carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
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.
Pregnant or nursing (lactating) women.
Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.