Adjusted Steroid Therapy in Children With Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The time until the first relapse
研究概览
简要总结
The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the investigators will adjusted the first steroids does to the response day. Our primary end point is : a lower adjusted dose is as good as the fix dose in the first year after diagnosis.
详细描述
About 90% of the patients will response to steroid therapy. The initial steroid dose is between 2mg/kg or 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The bases of this treatment have been put in the early 70s. Since then most of the study were focused on the duration of the therapy with a results that 8-12 weeks course is as good as 6 month. Studies have showed no difference in response rate between 2mg/kg to 60m2' although the difference in the dose in young children can rich to 25%. Other retrospective analysis been show that patients who response in the first 7-9 days tend to have lass relapses than other patients. In our nephrology clinic the investigators there is ongoing clinical study on low doses of steroid therapy for relapse of nephritic syndrome with good results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 who recently have been diagnosed with nephrotic syndrome.
排除标准
- •Children with nephrotic syndrome that can not be treated with steroids.
研究组 & 干预措施
Early response to prednisone treatment
intervention -children that will have a remission in 8 days (response) will get an adjusted steroids dose treatment.children that have a remission between 9-28 days will get a regular steroid dose.
干预措施: Prednisone (Drug)
结局指标
主要结局
The time until the first relapse
时间窗: 6 months
All Children with Nephrotic Syndrome will start a dose of 60 mg/m2 prednisone.patients that will response in 8 days (the first day with a negative or trace in the urine deep stick test)will receive adjusted lower steroid dose.the outcome is the time until the first relapse( positive protein in deep stick urine test,or low serum albumin with positive urine deep stick).the control group is the historical data from a prospective malty center observation study.
次要结局
- Number of relapse during first year(one year)