Mycophenolate Mofetil Versus Cyclophosphamide in the Induction Therapy of Pediatric Patients With Active Proliferative Lupus Nephritis: A Prospective, Randomized, Multicenter, Open-label, Parallel-arm Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Effective rate of LN treatment
研究概览
简要总结
A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population
详细描述
Scattered research in adults showed that both mycophenolate mofetil (MMF) and cyclophosphamide (CYC) can be used in the induction therapy of lupus nephritis. however data is limited in children.Therefore, the purpose of this study is to observe and compare the efficacy and safety of MMF and CYC as induction therapy for children with proliferative lupus nephritis through a multi-center open randomized controlled study.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only those who fully meet the following criteria can be considered for inclusion in this study:
- •Age 5-17 years old;
- •SLE patients who meet the updated 2019 eular/acr SLE classification criteria or 2012 SLICC diagnostic criteria;
- •According to the revised International Society of Nephrology / Society of renal pathology (isn/rps) classification in 2018, it conforms to active proliferative ln type III or IV, with or without type V;
- •Glomerular filtration rate EGFR ≥ 60 ml/min/1.73 m2;
- •24-hour urinary protein quantitation ≥ 25mg/kg, or urinary protein / creatinine 1.0mg/mg;
- •Blood routine WBC count ≥ 3.0*10^9/l, lymphocyte ≥ 0.5*10^9/l before enrollment;
- •No immunosuppressants such as cyclophosphamide, mycophenolate mofetil, cyclosporine A, tacrolimus, azathioprine, methotrexate, or biological agents such as rituximab, baileyoumab, and etaxel were used before enrollment.
排除标准
- •A known history of primary immunodeficiency, splenectomy, or any potential disease that makes participants vulnerable to infection;
- •Evidence of hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, or other serious infections;
- •Have any history of tumor or cancer;
- •Patients with lupus encephalopathy, diffuse alveolar hemorrhage, severe hemolytic anemia, blood routine platelet count lower than 10.0*10^9/l, glomerular filtration rate eGFR < 60 ml/min/1.73 m2, or patients with other serious complications have unstable vital signs;
- •Have severe gastrointestinal bleeding, pancreatitis, serious heart, liver, blood, endocrine system diseases;
- •Patients who are known to be allergic to mycophenolate mofetil, cyclophosphamide, glucocorticoids or any of the above drugs;
- •Patients who participated in other clinical trials within 3 months before enrollment;
- •The researcher judged that the patient's condition was not suitable for participants in this trial.
研究组 & 干预措施
Cyclophosphamide
Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day
干预措施: Cyclophosphamide (Drug)
Mycophenolate mofetil
Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Effective rate of LN treatment
时间窗: 6 months
complete remission and partial remission
次要结局
- complete remission time(6 months)
- Incidence of LN treatment failure(6 months)
- Incidence of creatinine doubling(6 months)
- LN recurrence rate(6 months)
- SLE recurrence rate(6 months)
- SLE disease activity score(6 months)
- partial remission time(6 months)
研究者
Xiaochuan Wu
Director of Pediatrics
Second Xiangya Hospital of Central South University