Defining relapse with asymptomatic seven-day nephrotic range proteinuria in steroid sensitive nephrotic syndrome to reduce steroid therapy usage: a prospective interventional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- In children with steroid sensitive nephrotic syndrome (SSNS) aged 3-18 years with 3 days of nephrotic range proteinuria, to estimate the proportion of children in whom steroid therapy is avoided by delaying the diagnosis of relapse till day 7 of asymptomatic nephrotic range proteinuria.
研究概览
简要总结
Incidence of nephrotic syndrome in children varies between 1.2 to 16.9 per lakh, with higher incidence in Asian children. It is characterized by heavy proteinuria, hypoalbuminemia and edema. Majority of the children (85-90%) respond to steroid therapy with complete resolution of proteinuria which is termed as steroid sensitive nephrotic syndrome (SSNS). Though the outcome of SSNS in satisfactory, 50% children have a frequent relapsing or steroid dependent course and 3-10% show late steroid resistance.
Relapse in nephrotic syndrome is defined as three consecutive days of nephrotic range proteinuria. This definition is empirical and not backed by any evidence from previous studies. Frequent relapsing nephrotic syndrome (FRNS) and steroid dependent nephrotic syndrome (SDNS) are at higher risk of steroid toxicity. In order to reduce the steroid toxicity, these children would require alternate immunosuppressive drugs like levamisole, mycophenolate mofetil (MMF), oral cyclophosphamide. These drugs are associated with serious adverse drug reactions like vasculitis, gastrointestinal disturbances, transaminitis, leukopenia etc.
Previous observational studies have reported spontaneous resolution of proteinuria in 33-50% between 5-10 days of onset of nephrotic range proteinuria. These studies suggest further waiting against the conventional definition of 3 consecutive days of nephrotic range proteinuria for relapse. Thus, a possible over diagnosis of FRNS/ SDNS and an unnecessary exposure to higher steroid dose and other immunosuppressive agents can be avoided.
Since the natural history of isolated proteinuria without symptoms in nephrotic syndrome is largely unknown, there is a need for prospective controlled studies for a more accurate definition of relapse in nephrotic syndrome. Hence, this study is being conducted to see if delaying the diagnosis of relapse till seven-days of asymptomatic nephrotic range proteinuria will reduce the need for steroid usage in SSNS children with 3 days of nephrotic range proteinuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Steroid sensitive nephrotic syndrome children aged 3 to 18 years with disease duration of more than 1 year and 3 consecutive days of nephrotic range proteinuria.
排除标准
- •Non adherence to urine protein diary maintenance, Development of edema within 3 days of onset of nephrotic range proteinuria, Severe infections mandating stress dose steroids, Steroid resistant nephrotic syndrome course in the past, Refusal of consent.
结局指标
主要结局
In children with steroid sensitive nephrotic syndrome (SSNS) aged 3-18 years with 3 days of nephrotic range proteinuria, to estimate the proportion of children in whom steroid therapy is avoided by delaying the diagnosis of relapse till day 7 of asymptomatic nephrotic range proteinuria.
时间窗: day 7
次要结局
- To study the time to remission(6 weeks)
- To compare the proportion of children in whom steroid therapy is avoided between infrequent relapsing nephrotic syndrome and frequent relapsing nephrotic syndrome/ steroid dependent nephrotic syndrome(6 weeks)
- To compare the proportion of children in whom steroid therapy is avoided between proteinuria associated with infections and without infections(6 weeks)
- To estimate the proportion of children in need for relapse therapy within 6 weeks of onset of proteinuria(6 weeks)
研究者
Paraselli Saiteja
AIIMS, New Delhi