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Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome (NEPHROVIR-2)

This study is currently recruiting participants.
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01609426
First received: April 25, 2012
Last updated: November 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Idiopathic Nephrotic Syndrome
 Genetic: DNA chip dedicated to the pharmacogenetic of steroids

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • define pharmacogenetic factors of steroid dependency [ Time Frame: 28.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides [ Time Frame: 28.5 months ] [ Designated as safety issue: No ]
  • Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area [ Time Frame: 28.5 months ] [ Designated as safety issue: No ]
    Number of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases existe.


Biospecimen Retention:   Samples With DNA

DNA Peripheral Blood Mononuclear Cells Plasma


Estimated Enrollment: 350
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
direct DNA extraction from peripheral blood cells

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.

  Eligibility

Ages Eligible for Study:   6 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609426

Contacts
Contact: George Deschênes, MD-PhD + 33 (0)1 40 03 24 67 georges.deschenes@rdb.aphp.fr

Locations
France
APHP Robert-Debré, Department of Pediatric Nephrology Recruiting
Paris, France, 75020
Contact: Georges Deschênes, MD-PhD     + 33 (0)1 40 03 24 67     georges.deschenes@rdb.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Georges Deschênes, MD-PhD Assistance Publique
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01609426     History of Changes
Other Study ID Numbers: NI11021, AOM 11002
Study First Received: April 25, 2012
Last Updated: November 16, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Proteinuria
idiopathic
nephrotic syndrome
herpesvirus
epidemiology
 immune response
interferon
steroid dependency
nephrotic disease: Idiopathic nephrotic syndrome

Additional relevant MeSH terms:
Nephrosis, Lipoid
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013