Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

NCT01609426 | Completed

• 2 other identifiers: NI11021AOM 11002
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Nephrotic Syndrome

Keywords

Proteinuria; idiopathic; nephrotic syndrome; herpesvirus; epidemiology; immune response; interferon; steroid dependency; nephrotic disease: Idiopathic nephrotic syndrome

Outcome Measures

Primary Outcomes (1)

• define pharmacogenetic factors of steroid dependency

  28.5 months

Secondary Outcomes (4)

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

  28.5 months

• Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area

  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

Study Arms (1)

children with idiopathic nephrotic syndrome

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

Genetic: DNA chip dedicated to the pharmacogenetic of steroids

Interventions

DNA chip dedicated to the pharmacogenetic of steroids GENETIC

direct DNA extraction from peripheral blood cells

children with idiopathic nephrotic syndrome

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Any children below 16 years of age with a first manifestation of idiopathic nephrotic syndrome commencing or having commenced in the Paris area

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

APHP Robert-Debré, Department of Pediatric Nephrology

Paris, 75020, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA Peripheral Blood Mononuclear Cells Plasma

MeSH Terms

Conditions

Nephrosis, Lipoid; Proteinuria; Nephrotic Syndrome; Herpes Simplex

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Georges Deschênes, MD-PhD

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: June 1, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

FR (1)