Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Nephrotic Syndrome Remission
研究概览
简要总结
Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well.
Response to this treatment is the most important prognostic factor and this patients has a benign disease course.
60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration.
guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion.
Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?
详细描述
Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The first line of therapy is prednisone and about 90% of the patients will
response to this treatment. The course of the disease is characterized of
recurrent relapses and repeated prednisone therapy. While prednisone doses and
therapy duration in the disease diagnosis has been based on multiple prospective
studies, the dose and therapy duration in the relapses was never challenged in a
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.
排除标准
- •Steroid resistance or treatment with Cyclosporin or Cellcept
研究组 & 干预措施
prednisone 60 mg/meter square Body Surface Aera
A - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end.
干预措施: prednisone 60 mg/meter square Body Surface Area (Drug)
prednisone 45 mg/meter square BSA
B- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended.
干预措施: prednisone 45 mg (Drug)
prednisone 30 mg/meter squer BSA
C- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended.
干预措施: prednisone 30 mg (Drug)
结局指标
主要结局
Nephrotic Syndrome Remission
时间窗: 3 days
Undetectable protein in urine for 3 days
次要结局
- Remission duration(Weeks)
研究者
Amit Dagan
DR. Amit Dagan
Rabin Medical Center