The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria 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 with mild proteinuria 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 markers 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 randomized to receive either prednisone p.o. or angiotensin-converting enzyme inhibitor(ACEI) p.o. We will follow up them for about 2.5 years and compare the efficacy and safety of both 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 (ISKDC class II)
- •Proteinuria < 25 mg/kg/d
排除标准
- •The children with congenital diseases
- •Proteinuria≥25 mg/kg/d
研究组 & 干预措施
group 1
Prednisone Drug : prednisone 1.5mg/kg/d for 4-6 weeks, then 1.5mg/kg/d qod for 4 weeks, reduce 5mg every 2-4 weeks If the proteinuria decreases by less than 50% after treating for two months, this candidate reaches the ending point.
干预措施: Prednisone (Drug)
group 2
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
干预措施: ACEI (Drug)
结局指标
主要结局
Disappearance of proteinuria
时间窗: 30 months
The proteinuria is \< 150mg/d
次要结局
- Disappearance of hematuria(30 months)
- Renal function(30 months)
研究者
Aihua Zhang
Hospital vice president
Nanjing Children's Hospital