NCT05514015招募中4 期
A Prospective, Randomized, Multicenter Clinical Trial Comparing the Efficacy and Safety of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in Primary Membranous Nephropathy
First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The complete response rate at 12 months;
研究概览
简要总结
This was a prospective, randomized, multicenter clinical trial. Seventy-eight patients with primary membranous nephropathy (PMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with corticosteroids in induction therapy and the control group was given rituximab monotherapy. After 6 months, patients who had decreased 24h urinary protein by > 25% but did not achieve CR were given rituximab maintenance therapy. The complete response rate at 12 months was measured.
详细描述
Study design A prospective, randomized , multicenter clinical study
Outcomes
- Primary objective To evaluate the efficacy of rituximab combined with corticosteroids or rituximab monotherapy in primary membranous nephropathy
- Secondary Objectives The safety of rituximab combined with corticosteroids or rituximab monotherapy in primary membranous nephropathy;
Primary outcome The complete response rate at 12 months;
- Secondary outcomes
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
- 未提供
排除标准
- •Patients with type 1 diabetes mellitus or type 2 diabetes mellitus complicated with diabetic nephropathy. Patients with a recent history of steroid-induced diabetes were eligible if renal biopsies show no evidence of secondary diabetic nephropathy within 6 months before the screening period
- •Patients with secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);
- •Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, mycophenolate (MMF), and azathioprine;
- •Receipt of any other study medication (within the last month);
- •Suspected or known allergy or immune reaction to rituximab, corticosteroids or any of their components (including excipients);
- •Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.
- •A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation;
- •Females with a positive pregnancy screening test or lactating or planning to become pregnant in the next 24 months. Female or male patients who were unwilling to use contraceptive methods throughout the study;
- •A history of mental illness;
- •Laboratory tests that meet the following criteria need to be excluded:
- •(1) Hemoglobin<80g/L; (2) Platelet < 80×109/L; (3) Neutrophil <1.0×109/L; (4) Aspartate aminotransferase (AST) or amino aminotransferase (ALT) > 2.5× upper limit of normal except in relation to the primary disease;
- •Very high-risk patients: presenting with life-threatening nephrotic syndrome, or unexplained rapid deterioration of renal function
- •Any patient judged by the investigator to be unsuitable for inclusion in the trial.
研究组 & 干预措施
Intervention arm
Experimental
rituximab combined with corticosteroids treatment group
干预措施: rituximab combined with corticosteroids (Drug)
Control arm
Active Comparator
Rituximab monotherapy treatment
干预措施: rituximab (Drug)
结局指标
主要结局
The complete response rate at 12 months;
时间窗: 12 months
The complete response rate at 12 months;
次要结局
- Median non-recurrence time;(24 months)
- Incidence of adverse events;(24 months)
- Median remission time;(24 months)
- CD19+ cell count, anti-PLA2R antibody expression level;(24 months)
- Response rates at 6, 12, 18 and 24 months (including the proportion of participants with complete response and partial response);(24 months)
- Proportion of patients without recurrence at 12, 18 and 24 months;(24 months)
- Renal function index: eGFR;(24 months)
- Cumulative dose of glucocorticoids;(24 months)
研究者
Wei Chen
Professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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