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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609426
First Posted: June 1, 2012
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Time Perspective: Other
Official Title: Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Resource links provided by NLM:


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 ]

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 ]
  • 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


Biospecimen Retention:   Samples With DNA
DNA Peripheral Blood Mononuclear Cells Plasma

Enrollment: 351
Actual Study Start Date: September 2012
Study Completion Date: June 2016
Primary Completion Date: June 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

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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609426


Locations
France
APHP Robert-Debré, Department of Pediatric Nephrology
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Georges Deschênes, MD-PhD Assistance Publique
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01609426     History of Changes
Other Study ID Numbers: NI11021
AOM 11002 ( Other Identifier: Assistance Publique )
First Submitted: April 25, 2012
First Posted: June 1, 2012
Last Update Posted: March 27, 2017
Last Verified: March 2017

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:
Syndrome
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases