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Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome (Nephrovir)
This study is currently recruiting participants.
Study NCT00577525.   Last updated on December 8, 2008.
Information provided by Assistance Publique - Hôpitaux de Paris
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Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome
Viral Infection of Lymphoid Cells Occuring at the First Manifestation of Idiopathic Nephrotic Syndrome

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.

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.

Observational
Case Control, Prospective
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Nephrosis, Lipoid
 
17855645,   17636340,   17554565,   16935903,   16267158,   16228184,   15882260,   15734130,   12814058,   12763891,   12761235,   12584259,   12478360,   12387184
 
Recruiting
360
December 2007
November 2011

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
Both
1 Year to 16 Years
No
Contact: Georges Deschênes, MD PhD 33 1 40 03 24 55 georges.deschenes@rdb.aphp.fr
France
 
NCT00577525
P070126
AOM 07018
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Georges DESCHENES, PHD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
December 2008
December 19, 2007
December 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.