Long-term safety of HSK39297 tablets in people with IgA nephropathy
Tests HSK39297 tablets over a longer time in people with IgA nephropathy.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Where in China
- Peking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07616700
- Record updated
- 1 June 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Open-Label Phase II Clinical Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in the Treatment of Primary IgA Nephropathy
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.
Inclusion: 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.
Exclusion: Severe concomitant diseases judged by the investigator to be incompatible with study participation; Suspected hypersensitivity to the investigational product or its class; 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; Other conditions that may interfere with the study or increase subject risk; Known or suspected hereditary or acquired complement deficiency; Active primary or secondary immunodeficiency; Pregnant or lactating females.