NCT07616700招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK
- •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
排除标准
- •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.
研究者
研究点 (2)
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