Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The median relapse-free survival
研究概览
简要总结
This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children clinically diagnosed with FRNS/SDNS/SRNS with complete clinical data;
- •age < 18 years old;
- •For the first time using RTX treatment, and used in nephrotic syndrome ease;
- •The follow-up for 1 year or more.
排除标准
- •Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis, etc.);
- •Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases;
- •Estimated glomerular filtration rate (GFR) <60mL/min/1.73m2.
研究组 & 干预措施
Sequential prevention group
According to the situation of B cells to rebuild the preventive use of rituxan, each 375 mg/m2.
干预措施: Rituximab (Drug)
Recurrent sequential group
In patients with recurrence after the use of rituxan, each 375 mg/m2.
干预措施: Rituximab (Drug)
结局指标
主要结局
The median relapse-free survival
时间窗: 1 year
The median relapse-free survival of nephrotic syndrome before and after RTX treatment was compared.
Different sequential group curative effect evaluation
时间窗: 1 year
After comparing the preventive RTX and recurrence RTX maintain annual recurrent treatment。
次要结局
- Risk factors for renal disease recurrence after RTX treatment.(1 year)
研究者
Bai Haitao, MD
Director
The First Affiliated Hospital of Xiamen University