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
  Purpose

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.


Condition
NEPHROSIS, LIPOID

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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
1
Case : Patients with steroid sensitive nephrotic syndrome
2
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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577525

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

Publications:

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
LATENT VIRAL INFECTION
GENOME HYBRIDIZATION
HERPES VIRUS
ADENOVIRUS

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

ClinicalTrials.gov processed this record on August 27, 2014