A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy

Recruiting now · Phase 2

Conditions studied: IgA Nephropathy (IgAN)

In brief

This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.

Key facts

Study ID

NCT07616700

Run by

Haisco Pharmaceutical Group Co., Ltd.

People needed

73

Starts

2025-08-25

Expected to finish

2026-12-26

Last updated by the study team

2026-06-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.
• eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation).
• Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.
• Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).
• Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose.
• Fertile males: highly effective contraception from signing informed consent until 90 days after last dose.
• Voluntarily provided written informed consent and able to comply with study procedures

You may not qualify if…

• Known or suspected hereditary or acquired complement deficiency.
• Active primary or secondary immunodeficiency.
• History of bone marrow / hematopoietic stem cell or solid organ transplantation.
• Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
• History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis.
• Severe concomitant diseases judged by the investigator to be incompatible with study participation.
• Suspected hypersensitivity to the investigational product or its class.
• Pregnant or lactating females.
• Other conditions that may interfere with the study or increase subject risk.

Where it is running

• Peking University First Hospital — Beijing, China (enrolling)
• Peking University First Hospital — Beijing, China

Full record on ClinicalTrials.gov

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