- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00577525
Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome (Nephrovir)
February 26, 2014 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
401
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75945
- Hospital Robert Debre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From the thirty nine units of general pediatrics and pediatric nephrology covering the Parisian area
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Case : Patients with steroid sensitive nephrotic syndrome
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2
Controls (matched for age and sexe with the first group)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Within the 3 days of the first manifestation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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4.5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Georges DESCHENES, PHD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1681/ASN.2006121346. Epub 2007 Sep 12.
- Ulinski T, Perrin L, Guigonis V, Driss F, Deschenes G, Bensman A. Remission of steroid- and CyA-resistant nephrotic syndrome using multiple drug immunosuppression. Pediatr Nephrol. 2007 Oct;22(10):1723-6. doi: 10.1007/s00467-007-0551-x. Epub 2007 Jul 17.
- Doucet A, Favre G, Deschenes G. Molecular mechanism of edema formation in nephrotic syndrome: therapeutic implications. Pediatr Nephrol. 2007 Dec;22(12):1983-90. doi: 10.1007/s00467-007-0521-3. Epub 2007 Jun 7.
- Lorton F, Raynot J, Letavernier B, Isapof A, Debiec H, Pressac M, Deschenes 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. doi: 10.1093/ndt/gfl459. Epub 2006 Aug 25. No abstract available.
- Lourdel S, Loffing J, Favre G, Paulais M, Nissant A, Fakitsas P, Creminon C, Feraille E, Verrey F, Teulon J, Doucet A, Deschenes 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. doi: 10.1681/ASN.2005040363. Epub 2005 Nov 2.
- Nathanson S, Cochat P, Andre JL, Guyot C, Loirat C, Nivet H, Deschenes G. Recurrence of nephrotic syndrome after renal transplantation: influence of increased immunosuppression. Pediatr Nephrol. 2005 Dec;20(12):1801-4. doi: 10.1007/s00467-005-2053-z. Epub 2005 Oct 14.
- Mansour H, Cheval L, Elalouf JM, Aude JC, Alyanakian MA, Mougenot B, Doucet A, Deschenes G. T-cell transcriptome analysis points up a thymic disorder in idiopathic nephrotic syndrome. Kidney Int. 2005 Jun;67(6):2168-77. doi: 10.1111/j.1523-1755.2005.00322.x.
- Frange P, Frey MA, Deschenes G. [Immunity and immunosuppression in childhood idiopathic nephrotic syndrome]. Arch Pediatr. 2005 Mar;12(3):305-15. doi: 10.1016/j.arcped.2004.12.015. French.
- Deschenes 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.
- Feraille E, Mordasini D, Gonin S, Deschenes 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. doi: 10.1111/j.1749-6632.2003.tb07255.x.
- Debiec H, Guigonis V, Mougenot B, Haymann JP, Bensman A, Deschenes 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. doi: 10.1097/01.asn.0000067649.64849.75. No abstract available.
- Deschenes 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. doi: 10.1093/ndt/18.3.454. No abstract available.
- Nathanson S, Lucidarme N, Landman-Parker J, Deschenes G. Long-term survival of renal graft complicated with Burkitt lymphoma. Pediatr Nephrol. 2002 Dec;17(12):1066-8. doi: 10.1007/s00467-002-0992-1. Epub 2002 Oct 8.
- Deschenes G. [LMXb1 generates the morphology of podocytes]. Arch Pediatr. 2002 Sep;9(9):1002-3. doi: 10.1016/s0929-693x(02)00071-4. No abstract available. French.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 20, 2007
Study Record Updates
Last Update Posted (Estimate)
February 27, 2014
Last Update Submitted That Met QC Criteria
February 26, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P070126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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