A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
2026年5月27日 更新者：Haisco Pharmaceutical Group Co., Ltd.
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.
研究概览
研究类型
介入性
注册 (估计的)
73
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：li fangqiong Li
- 电话号码：+86028-67258840
- 邮箱：lifangq@haisco.com
学习地点
-
-
-
Beijing、中国
- 招聘中
- Peking University First Hospital
-
接触：
- Zhang hong Zhang
- 电话号码：13811123738
- 邮箱：hongzh@bjmu.edu.cn
-
Beijing、中国
- 完全的
- Peking University First Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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 Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：200mg 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.
|
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.
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Incidence and severity of adverse events (AEs) during treatment.
大体时间：48 weeks
|
48 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ratio of 24-h urine protein-to-creatinine ratio (24h-UPCR) from baseline every 12 weeks during treatment
大体时间：48 weeks
|
48 weeks
|
|
|
Ratio of 24-h urine protein excretion (24h-UPE) from baseline every 12 weeks during treatment
大体时间：48 weeks
|
48 weeks
|
|
|
Change in estimated glomerular filtration rate (eGFR) from baseline every 24 weeks during treatment.
大体时间：48 weeks
|
48 weeks
|
|
|
Proportion of subjects with hematuria every 12 weeks during treatment.
大体时间：48 weeks
|
48 weeks
|
|
|
Change in Functional Assessment of Chronic Illness FACIT-F(Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline every 12 weeks during treatment
大体时间：48 weeks
|
The scale consists of 13 items, assessing patients' fatigue levels over the past seven days as well as fatigue impacts on cognition, physical function, psychology and social interaction.
The total score is the sum of scores for all items, ranging from 0 to 52.
A higher score indicates a lower degree of fatigue.
|
48 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetic (Cmax) of HSK39297 at 300 mg QD
大体时间：48 weeks
|
Exploratory Endpoint
|
48 weeks
|
|
Pharmacokinetic (Tmax) of HSK39297 at 300 mg QD
大体时间：48 weeks
|
exploratory endpoint
|
48 weeks
|
|
Pharmacokinetic (AUC0-tau) of HSK39297 at 300 mg QD
大体时间：48 weeks
|
exploratory endpoint
|
48 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年8月25日
初级完成 (估计的)
2026年12月5日
研究完成 (估计的)
2026年12月26日
研究注册日期
首次提交
2026年4月7日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HSK39297-204
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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