NCT07388810尚未招募不适用
Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome：An Open-label Randomized Controlled Trial
Mao Jianhua1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Relapse free survival rate
研究概览
简要总结
This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).
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
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years old and above with FRNS/SDNS
- •Before enrollment, achieved complete remission (urine protein/creatinine ratio (morning urine or 24-hour urine) ≤ 20mg/mmol (0.2mg/mg) or < 100mg/m2/d, or test strip result negative or trace)
- •Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)
- •Glomerular filtration rate (eGFR) > 60ml/min/1.73m2
- •The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study
排除标准
- •Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)
- •Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.
- •Severe leukopenia (white blood cells < 3.0×109/L), severe anemia (hemoglobin < 8.9 g/dl), thrombocytopenia (platelets < 100×109/L), or liver dysfunction (alanine aminotransferase/aspartate aminotransferase > 2 times the upper limit of normal)
- •Received live vaccines within 1 month prior to screening
- •Currently participating in other drug clinical trials
- •Other conditions that the investigator deems make the patient unsuitable for this study
研究组 & 干预措施
One dose group
Active Comparator
1 dose of 375mg/m2 BSA ripertamab.
干预措施: ripertamab (Drug)
Two doses group
Experimental
2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days).
干预措施: ripertamab (Drug)
结局指标
主要结局
Relapse free survival rate
时间窗: 1 year
Relapse free survival rate at 1 year
次要结局
- Recurrence frequency at 6 and 12 months(1 year)
- Cumulative corticosteroid dose(1 year)
- Median recurrence-free survival(18 months)
- B-cell count(18 months)
- The occurrence and severity of adverse events(18 months)
研究者
Mao Jianhua
Professor
The Children's Hospital of Zhejiang University School of Medicine
研究点 (1)
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