NCT07289763招募中2 期
Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年12月31日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, regardless of gender;
- •Weight ≥40.0 kg at screening;
- •Diagnosed as primary membranous nephropathy through kidney biopsy.
排除标准
- •Secondary membranous nephropathy.
- •Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation.
- •Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period.
- •Subjects who have a malignant tumor or a history of malignant tumor
- •Subjects who have undergone major surgery within the previous 3 months, or plan to undergo major surgery during the study period.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: SHR-2173 injection (Drug)
Treatment group B
Experimental
干预措施: SHR-2173 injection (Drug)
Treatment group C
Experimental
干预措施: SHR-2173 injection (Drug)
结局指标
主要结局
Adverse events
时间窗: Week0, 2, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 48 52
12-lead ECG
时间窗: Week4, 8, 12, 24, 28, 36, 52
次要结局
- The proportion of subjects who achieved overall response (including complete response (CR) and partial response (PR)).(Week 12, 24, 36, 52)
- The proportion of subjects who achieved CR(Week 12, 24, 36, 52)
- The proportion of subjects who achieved PR(Week 12, 24, 36, 52)
研究者
研究点 (1)
Loading locations...
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