Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: June 2016

Detailed Description

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.

Interventions

  • Genetic: DNA chip dedicated to the pharmacogenetic of steroids
    • direct DNA extraction from peripheral blood cells

Arms, Groups and Cohorts

  • children with idiopathic nephrotic syndrome
    • children below 16 years of age with a steroid dependent nephrotic syndrome

Clinical Trial Outcome Measures

Primary Measures

  • define pharmacogenetic factors of steroid dependency
    • Time Frame: 28.5 months

Secondary Measures

  • parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides
    • Time Frame: 28.5 months
  • Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area
    • Time Frame: 28.5 months
    • Number of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases exist.
  • Analysis of cortico-dependence factors
    • Time Frame: Day 1
    • Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients
  • Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome
    • Time Frame: Day 1
    • Comparison of polymorphisms of all patients suffering from the Idiopathic Nephrotic Syndrome, with general population

Participating in This Clinical Trial

Inclusion Criteria

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

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Georges Deschênes, MD-PhD, Principal Investigator, Assistance Publique

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