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Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome (Nephrovir)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: December 19, 2007
Last updated: February 26, 2014
Last verified: February 2014
The primary purpose of the study is to evaluate the association of a latent infection of lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The thirty nine units of general pediatrics and pediatric nephrite covering the parisian area will participate to the study. We speculate that hybridization of the genome, or a part of the genome, of a virus in lymphoid cells is responsible specific changes of genes expression, leading to the development of the disease.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Viral Infection of Lymphoid Cells Occuring at the First Manifestation of Idiopathic Nephrotic Syndrome

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome [ Time Frame: Within the 3 days of the first manifestation ]

Secondary Outcome Measures:
  • Steroid sensitivity will be checked by 1 month of prednisone therapy according to the recommendation of the " SOCIETE DE NEPROLOGIE PEDIATRIQUE" and steroid dependency will be checked at 4.5 months of prednisone therapy. [ Time Frame: 4.5 months ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, red cells and DNA

Enrollment: 401
Study Start Date: December 2007
Study Completion Date: February 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Case : Patients with steroid sensitive nephrotic syndrome
Controls (matched for age and sexe with the first group)

Detailed Description:
An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease and viral genome of EBV, CMV, HHV6, HHV7 as well as adenovirus will be searched for using PCR reaction in total blood DNA extract. The frequency of a latent hybridization of virus genome within human genome will be compared between patients with steroid sensitive nephrotic syndrome and controls matched for age and sex. Secondary studies will include a comparison of steroid dependency in nephrotic patients according to the occurence of a latent viral hybridization, the epidemiology of idiopathic nephrotic syndrome in the Parisian area and a pharmacogenetic analysis of steroid sensitivity and dependency. If necessary, the chromosomal localization of viral hybridization will be studied with fluorescence in situ hybridization using specific probes.

Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
From the thirty nine units of general pediatrics and pediatric nephrology covering the Parisian area

Inclusion Criteria:

  • proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case
  • No history of renal disease
  • Normal C3 and negativity for hepatitis B and C

Exclusion Criteria:

  • no medical insurance
  • inclusion in another study
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Please refer to this study by its identifier: NCT00577525

Hospital Robert Debre
Paris, France, 75945
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Georges DESCHENES, PHD Assistance Publique - Hôpitaux de Paris
  More Information


Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00577525     History of Changes
Other Study ID Numbers: P070126
Study First Received: December 19, 2007
Last Updated: February 26, 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Additional relevant MeSH terms:
Nephrotic Syndrome
Virus Diseases
Nephrosis, Lipoid
Kidney Diseases
Urologic Diseases processed this record on May 22, 2017