jRCT2041230037招募中不适用
The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome (Study of Rituximab for the Treatment for Idiopathic Membranous Nephropathy with Nephrotic Syndrome)
未提供0 个研究点目标入组 88 人开始时间: 2023年6月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 15age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent (1)
- •Patients who are diagnosed as having nephrotic syndrome prior to the obtainment of informed consent (1) and receive no steroids or immunosuppressants within 12 weeks prior to the obtainment of informed consent
- •Patients with urine protein-creatinine ratio 3.5 g/gCr or more at the screening (1)
- •Patients with hypoalbuminemia (serum albumin 3.0 g/dL or less) at the screening (1)
- •Patients aged 15 years or older at informed consent (1)
- •Patients who give voluntary written consent after having received adequate information on this study (legally acceptable representatives should also give consent for underage patients, and informed assent should be obtained from children)
排除标准
- •Patients with primary nephrotic syndrome other than membranous nephropathy (IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis and so forth), and patients with secondary nephrotic syndrome (autoimmune disease, metabolic disease, infection, allergic/hypersensitive disease, tumor, and drug-induced disease)
- •Patients with the renal function lowered (eGFR less than 30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening (1)
- •Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent (1) for idiopathic membranous nephropathy
- •Patients who have participated in another clinical study within 12 weeks prior to the informed consent (1) (enrollment is allowed for those participating in a clinical study in the range of Indications or Dosage and Administration in Japan) or patients who are participating in another study
- •Patients with history of renal transplant
- •Patients with poorly controlled diabetes (HbA1c of 8.0% or higher)
- •Patients who have or are suspected of having an active infection at the time of informed consent (1)
- •Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody (patients with positive HBs antibody and/or HBc antibody can be enrolled only when HBV-DNA test is negative [less than the detection limit]), or patients with positive HIV antibody or HTLV-1 antibody at the time of the screening (1)
- •Patients with leukopenia (less than 2,000 /mm3), neutropenia (less than 1,000 /mm3), or lymphopenia (less than 500 /mm3) at the time of the screening (1)
- •Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein-containing products
- •Patients who are judged to be life-threatening nephrotic syndrome by the investigator or a subinvestigator
- •Patients with serious comorbidity (e.g., hepatic, renal (excluding idiopathic membranous nephropathy with nephrotic syndrome), cardiac, lung, hematologic, or brain disease)
- •Female patients who are pregnant, lactating, or potentially pregnant, patients who are not willing to use contraceptive measures during the study period, or female patients not willing to use contraceptive measures until 12 months after the last dose of study drug (except for female patients who are unale to pregnant)
- •Patients who are judged to be unsuitable by the investigator or a subinvestigator
结局指标
主要结局
-
Percentage of patients achieving ICR I
次要结局
- Percentage of patients who are CR, ICR I, ICR II, NR or PR at each assessment time point(each assessment time point)
- Duration before achieving CR, ICR I, ICR II or PR
- Urine protein-creatinine ratio
- eGFR
- B-cells (CD19-positive and CD20-positive cells)
- Expression of human anti-chimeric antibodies
- Serum rituximab concentration
研究者
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