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Completed

NCT Number: NCT01609426

Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

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.

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Key information

Conditions

Idiopathic Nephrotic Syndrome DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Herpes Simplex Herpesviridae Infections Infections Kidney Diseases Male Urogenital Diseases Nephrosis Nephrosis, Lipoid Nephrotic Syndrome Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Virus Diseases

Age range

6 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP Robert-Debré, Department of Pediatric Nephrology

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA chip dedicated to the pharmacogenetic of steroids

Genetic

direct DNA extraction from peripheral blood cells

Primary outcomes

  1. define pharmacogenetic factors of steroid dependency

    Time frame: 28.5 months

Secondary outcomes

  1. parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides

    Time frame: 28.5 months

  2. 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.

  3. Analysis of cortico-dependence factors

    Time frame: Day 1

    Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients

  4. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: NEPHROVIR-2

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 1, 2012
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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