NEPHROSIS, LIPOIDNephrovirNCT00577525
Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome
An observational study of NEPHROSIS, LIPOID, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- NEPHROSIS, LIPOID
- How many people
- 401 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: From the thirty nine units of general pediatrics and pediatric nephrology covering the Parisian area
Who may be able to join
- 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
Who cannot join
- no medical insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- NEPHROSIS, LIPOID
- Keywords
- LATENT VIRAL INFECTION, GENOME HYBRIDIZATION, HERPES VIRUS, ADENOVIRUS
- Medical subject headings
- Nephrosis, Lipoid, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Case : Patients with steroid sensitive nephrotic syndrome | |
| 2 | Controls (matched for age and sexe with the first group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome
Measured: Within the 3 days of the first manifestation
Secondary outcomes (1)
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.
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for NEPHROSIS, LIPOIDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges DESCHENES, PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577525
- Sponsor's protocol ID
- P070126
- Acronym
- Nephrovir
- Status last verified
- Feb 2014
- First submitted
- 19 Dec 2007
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17855645Ulinski 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.
PubMed 17636340Doucet 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.
PubMed 17554565Lorton 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.
PubMed 16935903Lourdel 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.
PubMed 16267158Nathanson 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.
PubMed 16228184Mansour 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.
PubMed 15882260Frange 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.
PubMed 15734130Deschenes 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.
PubMed 12814058Feraille 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.
PubMed 12763891Debiec 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.
PubMed 12761235Deschenes 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.
PubMed 12584259Nathanson 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.
PubMed 12478360Deschenes 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.
PubMed 12387184
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Infection of Lymphoid Cells Occuring at the First Manifestation of Idiopathic Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT00577525
- Acronym / sponsor ID
- Nephrovir / P070126
- Conditions
- NEPHROSIS, LIPOID
- Keywords
- LATENT VIRAL INFECTION, GENOME HYBRIDIZATION, HERPES VIRUS, ADENOVIRUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Case : Patients with steroid sensitive nephrotic syndrome |
| 2 | – | –Controls (matched for age and sexe with the first group) |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- From the thirty nine units of general pediatrics and pediatric nephrology covering the Parisian area
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- no medical insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Results publication: PubMed 17855645Sellier-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.
- Results publication: PubMed 17636340Ulinski 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.
- Results publication: PubMed 17554565Doucet 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.
- Results publication: PubMed 16935903Lorton 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.
- Results publication: PubMed 16267158Lourdel 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.
- Results publication: PubMed 16228184Nathanson 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.
- Results publication: PubMed 15882260Mansour 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.
- Results publication: PubMed 15734130Frange 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.
- Results publication: PubMed 12814058Deschenes 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.
- Results publication: PubMed 12763891Feraille 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.
- Results publication: PubMed 12761235Debiec 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.
- Results publication: PubMed 12584259Deschenes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges DESCHENES, PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NEPHROSIS, LIPOID, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00577525, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.