Long-term safety and effectiveness of HSK39297 tablets in IgA nephropathy patients who completed prior study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase II study enrolling adults with IgA nephropathy who completed the prior HSK39297-202 trial. Participants start at 200 mg once daily and may increase to 300 mg daily after 8–12 weeks if 24-hour urine protein remains above 1 g and no dose-limiting adverse events occur. Treatment is followed by a 4-week safety washout period. Eligible participants must have adequate kidney function, stable background therapy, and vaccination status as required, with ongoing informed consent and contraception requirements as applicable. Primary objectives focus on long-term safety and efficacy of HSK39297 in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.
2. eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation).
3. Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.
4. Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).
5. 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.
6. Voluntarily provided written informed consent and able to comply with study procedures

Exclusion Criteria:

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

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting
• Peking University First Hospital
  Beijing, China Completed

Study contacts

• Study coordinator: li fangqiong Li
• Email: lifangq@haisco.com
• Phone: +86028-67258840

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.