NCT07582133招募中2 期
A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 Capsules in Patients With Primary IgA Nephropathy
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;
- •Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.
排除标准
- •Hypersensitivity to the study drug or its components；
- •History of immunodeficiency disorders；
- •History of invasive encapsulated bacterial infection；
- •History of malignant neoplasm；
- •The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2；
研究组 & 干预措施
HRS-5965 Capsules
Experimental
干预措施: HRS-5965 Capsules (Drug)
研究者
研究点 (1)
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