Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 主要终点
- Complete response
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3-18 years old, regardless of sex;
- •SLE patients who meet the 2019 EULAR/ACR SLE criteria or the 2012 SLICC diagnostic criteria;
- •Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V);
- •White blood cell count ≥3.0×10^9/L, and lymphocyte count ≥ 0.5× 10^9/L and CD20 (or CD19)≥1/ul;
- •No cyclophosphamide or rituximab induction therapy was used before enrollment;
- •Informed consent form is signed by the guardian and children over 8 years old;
- •In the active stage of the disease, the 24-hour urine protein quantification ≥25mg/kg, or the urine protein/creatinine ≥1.0mg/mg;
- •Estimated GFR≥60ml/min/1.73m^2 (improved Swchartz formula).
排除标准
- •Patients with lupus encephalopathy;
- •Estimated GFR<60ml/min/1.73m^2(Swchartz formula);
- •HBV-antigen positive, HCV or HIV antibody positive;
- •Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;
- •Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide;
- •Severe heart failure and liver function damage;
- •Patients who is not suitable to participate in this study judged by the researchers.
结局指标
主要结局
Complete response
时间窗: 6 months after the intervention
Patients are defined as having a complete response if they meet all the following conditions: ①Proteinuria is \<0.5 g/1.73m\^2 per day or protein-creatinine ratio from a morning spot urine \<0.2 g/g ②Renal function is stabilized or improved（±10%-15% of baseline）
Partial response
时间窗: 6 months after the intervention
A partial response is defined for patients who do not meet the complete response criteria but satisfy both of the following criteria: ①Urinary protein is reduced by ≥ 50% from baseline, and protein-creatinine ratio from a morning spot urine \< 3.0g/g ②Renal function is stable or improved（±10%-15% of baseline）.
No kidney response
时间窗: 6 months after the intervention
No kidney response is defined as failure to achieve partial or complete response.
次要结局
- SLEDAI scores(6 months after the intervention)