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临床试验/NCT01609426
NCT01609426已完成不适用

Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
351
试验地点
1
主要终点
define pharmacogenetic factors of steroid dependency

研究概览

简要总结

The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

详细描述

Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
6 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children below 16 years
  • first manifestation of nephrotic syndrome
  • steroid sensitivity according to the recommendations of the french "pediatric society nephrology"

排除标准

  • patients who don't stay in Paris during the study

结局指标

主要结局

define pharmacogenetic factors of steroid dependency

时间窗: 28.5 months

次要结局

  • Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area(28.5 months)
  • parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides(28.5 months)
  • Analysis of cortico-dependence factors(Day 1)
  • Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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