NCT05914155进行中（未招募）3 期
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 （PRIME Study）
Shoichi Maruyama MD PhD18 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年6月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
- 试验地点
- 18
- 主要终点
- Percentage of patients achieving ICR I
研究概览
简要总结
To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo kidney biopsy and are diagnosed as having idiopathic membranous nephropathy prior to the obtainment of informed consent
- •Patients who are diagnosed as having nephrotic syndrome prior to the obtainment of informed consent 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 at the screening
- •Patients with hypoalbuminemia (serum albumin ≤ 3.0 g/dL) at the screening
- •Patients aged 15 years or older at informed consent
- •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 <30 mL/min/1.73 m2 based on CKD-EPIcr formula) at the screening
- •Patients who have used anti-CD20 antibody including rituximab (genetical recombination) prior to the informed consent for idiopathic membranous nephropathy
- •Patients who have participated in another clinical study within 12 weeks prior to the informed consent (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 to have active infection (infection requiring treatment with systemic antimicrobial, antifungal, or antiviral agents) at the time of informed consent
- •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
- •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
- •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
研究组 & 干预措施
Placebo group in double-blind phase
Placebo Comparator
干预措施: Placebo (Drug)
Rituximab group in double-blind phase
Active Comparator
干预措施: Rituximab (genetical recombination) (Drug)
Rituximab group in open-label phase
Other
干预措施: Rituximab (genetical recombination) (Drug)
结局指标
主要结局
Percentage of patients achieving ICR I
时间窗: up to 26 weeks
Achieving ICR I is defined as "Urine protein-creatinine ratio \< 1.0 g/gCr".
次要结局
- Expression of HACA(up to 26 weeks)
- Serum rituximab (genetical recombination) concentration(up to 26 weeks)
- B-cells (CD19-positive and CD20-positive cells)(up to 26 weeks)
- Percentage of patients who are CR, ICR I, ICR II, NR or PR(up to 26 weeks)
- Duration before achieving CR, ICR I, ICR II or PR(up to 26 weeks)
- eGFR(up to 26 weeks)
- Urine protein-creatinine ratio(up to 26 weeks)
研究者
Shoichi Maruyama MD PhD
Professor
Nagoya University
研究点 (18)
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