Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00577525

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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

Biospecimen Description:

whole blood, serum, red cells and DNA

Estimated Enrollment:	360
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	March 2011 (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

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

Contacts

Contact: Georges Deschênes, MD PhD

33 1 40 03 24 55

georges.deschenes@rdb.aphp.fr

Locations

France
Hospital Robert Debre	Recruiting
Paris, France, 75945
Principal Investigator: Georges Deschênes, MD PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Georges DESCHENES, PHD

Assistance Publique - Hôpitaux de Paris

More Information

Publications of Results:

Sellier-Leclerc AL, Duval A, Riveron S, Macher MA, Deschenes G, Loirat C, Verpont MC, Peuchmaur M, Ronco P, Monteiro RC, Haddad E. A humanized mouse model of idiopathic nephrotic syndrome suggests a pathogenic role for immature cells. J Am Soc Nephrol. 2007 Oct;18(10):2732-9. Epub 2007 Sep 12.

Ulinski T, Perrin L, Guigonis V, Driss F, Deschênes G, Bensman A. Remission of steroid- and CyA-resistant nephrotic syndrome using multiple drug immunosuppression. Pediatr Nephrol. 2007 Oct;22(10):1723-6. Epub 2007 Jul 17.

Doucet A, Favre G, Deschênes G. Molecular mechanism of edema formation in nephrotic syndrome: therapeutic implications. Pediatr Nephrol. 2007 Dec;22(12):1983-90. Epub 2007 Jun 7.

Lorton F, Raynot J, Letavernier B, Isapof A, Debiec H, Pressac M, Deschênes G, Lenoir M, Ross-Cerdan L, Grapin C, Bensman A, Ulinski T. Gross proteinuria post transplant in a child with nephrotic syndrome of the Finnish type--mechanical vs immunological pathogenesis. Nephrol Dial Transplant. 2006 Dec;21(12):3579-82. Epub 2006 Aug 25. No abstract available.

Lourdel S, Loffing J, Favre G, Paulais M, Nissant A, Fakitsas P, Créminon C, Féraille E, Verrey F, Teulon J, Doucet A, Deschênes G. Hyperaldosteronemia and activation of the epithelial sodium channel are not required for sodium retention in puromycin-induced nephrosis. J Am Soc Nephrol. 2005 Dec;16(12):3642-50. Epub 2005 Nov 2.

Nathanson S, Cochat P, André JL, Guyot C, Loirat C, Nivet H, Deschênes G. Recurrence of nephrotic syndrome after renal transplantation: influence of increased immunosuppression. Pediatr Nephrol. 2005 Dec;20(12):1801-4. Epub 2005 Oct 14.

Mansour H, Cheval L, Elalouf JM, Aude JC, Alyanakian MA, Mougenot B, Doucet A, Deschênes G. T-cell transcriptome analysis points up a thymic disorder in idiopathic nephrotic syndrome. Kidney Int. 2005 Jun;67(6):2168-77.

Frange P, Frey MA, Deschênes G. [Immunity and immunosuppression in childhood idiopathic nephrotic syndrome] Arch Pediatr. 2005 Mar;12(3):305-15. Review. French.

Deschênes G, Feraille E, Doucet A. [Cellular and molecular mechanisms of sodium pump activation in experimental models of nephrotic syndrome] Nephrologie. 2003;24(3):121-6. French.

Féraille E, Mordasini D, Gonin S, Deschênes G, Vinciguerra M, Doucet A, Vandewalle A, Summa V, Verrey F, Martin PY. Mechanism of control of Na,K-ATPase in principal cells of the mammalian collecting duct. Ann N Y Acad Sci. 2003 Apr;986:570-8. Review.

Debiec H, Guigonis V, Mougenot B, Haymann JP, Bensman A, Deschênes G, Ronco PM. Antenatal membranous glomerulonephritis with vascular injury induced by anti-neutral endopeptidase antibodies: toward new concepts in the pathogenesis of glomerular diseases. J Am Soc Nephrol. 2003 Jun;14 Suppl 1:S27-32. Review. No abstract available.

Deschênes G, Feraille E, Doucet A. Mechanisms of oedema in nephrotic syndrome: old theories and new ideas. Nephrol Dial Transplant. 2003 Mar;18(3):454-6. No abstract available.

Nathanson S, Lucidarme N, Landman-Parker J, Deschênes G. Long-term survival of renal graft complicated with Burkitt lymphoma. Pediatr Nephrol. 2002 Dec;17(12):1066-8. Epub 2002 Oct 8.

Deschenes G. [LMXb1 generates the morphology of podocytes] Arch Pediatr. 2002 Sep;9(9):1002-3. French. No abstract available.

Responsible Party:	Department of clinical research and development ( Christophe AUCAN )
Study ID Numbers:	P070126, AOM 07018
Study First Received:	December 19, 2007
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00577525
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

LATENT VIRAL INFECTION
GENOME HYBRIDIZATION
HERPES VIRUS
ADENOVIRUS

Study placed in the following topic categories:

Virus Diseases
Nephrosis
Nephrosis, Lipoid
Urologic Diseases

Adenoviridae Infections
Kidney Diseases
Nephrotic Syndrome

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on February 10, 2009