NCT05136456进行中（未招募）2 期
A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR1459 Tablets in the Treatment of Primary Membranous Nephropathy (PMN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 19
- 主要终点
- Proportion of subjects achieving complete or partial remission at week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of SHR1459 tablets in patients with primary membranous nephropathy.
详细描述
This study is a phase II study to evaluate the efficacy and safety of SHR1459 tablets 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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of primary membranous nephropathy based on renal biopsy before or during screening
- •Have not received any previous immunosuppressive therapy for primary membranous nephropathy or relapse after the treatment has achieved complete or partial remission (comprehensive judgment and recording by the investigator)
- •PLA2R-Ab titer ≥20RU/mL at screening
- •24-hour urinary protein ≥ 3.5g/d at screening
- •Have eGFR ≥ 60 mL/min/1.73 m2 (based on CKD-EPI formula) at screening
排除标准
- •Any clue for coexist of secondary membranous nephropathy from medical records, laboratory tests or kidney biopsy
- •Existence of clinically significant infection within 1 month before screening,
- •Severe or not well controlled other complications
- •Abnormal in white blood cell count, neutrophil count, lymphocyte count or platelet count at screening, which were considered unfit for participating judged by investigators
- •ALT > 2 times ULN and/or AST > 2 times ULN and/or bilirubin >2 times ULN at screening
- •Subject has evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- •Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody at screening;
研究组 & 干预措施
SHR1459 High Dose
Active Comparator
Drug: SHR0302 SHR1459 oral 24 weeks
干预措施: SHR1459 High Dose (Drug)
Placebo
Placebo Comparator
Drug: Placebo Placebo oral 24 weeks
干预措施: Placebo (Drug)
SHR1459 Low Dose
Active Comparator
Drug: SHR1459 SHR1459 oral 24weeks
干预措施: SHR1459 Low Dose (Drug)
结局指标
主要结局
Proportion of subjects achieving complete or partial remission at week 24
时间窗: 24 Weeks
Proportion of subjects achieving complete or partial remission at week 24
次要结局
未报告次要终点
研究者
研究点 (19)
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