The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disappearance of proteinuria
研究概览
简要总结
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
详细描述
Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d
排除标准
- •The children with congenital diseases Proteinuria < 50 mg/kg/d
研究组 & 干预措施
Prednisone & Cyclophosphamide
Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Prednisone (Drug)
Prednisone & Cyclophosphamide
Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Cyclophosphamide(CTX) (Drug)
Prednisone & Cyclophosphamide
Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Angiotensin-converting enzyme inhibitor(ACEI) (Drug)
Prednisone & Cyclophosphamide
Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Methylprednisolone (Drug)
Prednisone & Mycophenolate mofetil
Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Prednisone (Drug)
Prednisone & Mycophenolate mofetil
Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Mycophenolate mofetil(MMF) (Drug)
Prednisone & Mycophenolate mofetil
Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Angiotensin-converting enzyme inhibitor(ACEI) (Drug)
Prednisone & Mycophenolate mofetil
Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Methylprednisolone (Drug)
Prednisone & Leflunomide
Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d.
Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Prednisone (Drug)
Prednisone & Leflunomide
Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d.
Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Leflunomide(LEF) (Drug)
Prednisone & Leflunomide
Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d.
Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Angiotensin-converting enzyme inhibitor(ACEI) (Drug)
Prednisone & Leflunomide
Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d.
Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Disappearance of proteinuria
时间窗: 30 mo
The proteinuria is \< 150mg/d
次要结局
- Disappearance of hematuria(30 mo)
- Renal function(30 mo)
研究者
Aihua Zhang
Hospital vice president
Nanjing Children's Hospital