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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00577525
First received: December 19, 2007
Last updated: February 26, 2014
Last verified: February 2014

December 19, 2007
February 26, 2014
December 2007
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00577525 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, red cells and DNA

Non-Probability Sample

From the thirty nine units of general pediatrics and pediatric nephrology covering the Parisian area

NEPHROSIS, LIPOID
Not Provided
  • 1
    Case : Patients with steroid sensitive nephrotic syndrome
  • 2
    Controls (matched for age and sexe with the first group)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
February 2012
July 2010   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
France
 
NCT00577525
P070126
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Georges DESCHENES, PHD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP