Combination of Rituximab and Cyclosporine in the Treatment of Primary Membranous Nephropathy
Efficacy and Safety of Rituximab Combined With Cyclosporine for Primary Membranous Nephropathy
High-grade proteinuria is one of the key determinants of adverse renal prognosis in patients with primary membranous nephropathy (PMN).The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.
研究概览
详细说明
Primary membranous nephropathy (PMN) is one of the most common causes of nephrotic syndrome among Chinese adults. For patients with high-grade proteinuria , immunosuppressive therapy is needed. B cell-depleting agent Rituximab is a recommended treatment Regimen in maintaining remission but the response to Rituximab is relatively slow. Calcineurin inhibitors lead to earlier reductions in proteinuria but presenting higher relapse rates in the long follow-up period.Combination therapy may provide both earlier proteinuria remission and durable effect. This is a multi-center, randomized, open-label study conducted in adult patients with biopsy-proven PMN. The main purpose of this study is to determine whether Rituximab combined with Cyclosporine is superior to Rituximab monotherapy in inducing remission of proteinuria in patients with PMN.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Fang Wang, Doctor
- 电话号码:01083572388
- 邮箱:wangfang@bjmu.edu.cn
学习地点
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Beijing、中国
- 招聘中
- Peking University First Hospital
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接触:
- Fang Wang
- 电话号码:86-10-83572388
- 邮箱:wangfang@bjmu.edu.cn
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-80 years.
- Primary membranous nephropathy confirmed by renal biopsy.
- 24-hour urinary protein quantification > 5.0 g/24h and serum albumin < 30 g/L after at least 3 months of treatment with RAAS blockers.
- eGFR ≥ 40 mL/min/1.73 m².
- Well-controlled blood pressure (≤140/90 mmHg) in the recent 3 months.
- Signed informed consent form.
Exclusion Criteria:
- Secondary causes of membranous nephropathy, such as that secondary to systemic lupus erythematosus, malignant tumors, hepatitis B virus infection, heavy metal poisoning;
- Coexistence of other types of kidney diseases;
- Use of rituximab within the past 12 months;
- Use of corticosteroids, cyclophosphamide, cyclosporine, mycophenolate mofetil, or leflunomide within the past 3 months;
- Active infection: active tuberculosis, HBsAg positivity or HBV-DNA indicating viral replication, positive HCV antibody, HIV infection;
- New-onset cardiovascular or cerebrovascular diseases within the past 3
- Severe liver disease: AST and ALT > 3 times range upper limit ;
- Uncontrolled severe hypertension;
- Newly diagnosed or recurrent malignant tumors within the past 5 years;
- Coexistent autoimmune diseases;
- Pregnancy, lactation, or recent plans for pregnancy;
- Life expectancy less than 12 months;
- Participation in other clinical trials within the past 3 months;
- Unwillingness to sign the informed consent form;
- Any other condition deemed unsuitable for the study by the investigator.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:combination therapy
Rituximab combined with cyclosporine |
The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml.Oral cyclosporine will be started at 3 mg/kg/day and continued for 6 months, followed by a 2-month tapering period. |
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有源比较器:monotherapy
Rituximab |
The first cycle of rituximab was given at a dose of 1000 mg i.v. on day 1 and day 15.Patients were retreated with rituximab (1000mg ) when CD20 B-cell count was more than 5 cells/ml. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Remission Status
大体时间:At 3 months after randomization
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the proportion of subjects to reach the composite of maintaining complete remission or partial remission at 3 months after randomization |
At 3 months after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Remission at 6 months and 12 months
大体时间:From enrollment to the end of follow-up at 12 months
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The proportions of patients achieving complete remission or partial remission at 6 and 12 months of treatment. |
From enrollment to the end of follow-up at 12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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