Anti-BK Virus Immune Response and Kidney Transplantation (BKv)
Role of Specific Immune Cellular Response in the Control of BK Virus Infection: Prospective Study, Monocentric and Longitudinal During the First Nine Months After a Kidney Transplantation
BK virus infections are very frequent during months following a kidney transplantation: a viral reactivation is observed for almost 50% of patients during first year. This reactivation leads to a viremia for 10 to 15% of patient during this same period. The most frequent complication is interstitial nephritis for 2 to 8% of patients (27 patients representing 2.7% during 6 years in Nantes).
An intensive et persisting viral replication, assessed by detection of high blood viral load, could evolved to a viral nephropathy which lead to a very pejorative functional issue for the graft.
Biological follow-up of these infections lay on the measures of viral load. Their positivity must alert the physician and lead him to modulate immunosuppressive treatment.
Actually, there is no real consensus about the modalities of pharmacological immunosuppression decrease (decrease dose or change of molecule).
Specific lymphocytic anti-BKv evaluated on several cohorts of patients permit to prove:
- weakness of immune cellular response for patient with high viremia
- increase of this response when viral load decrease These studies laid on detection of INFg synthesis by Elispot after stimulation with viral antigens and in vitro cellular expansion.
New prospective and longitudinal data comparing the immune cellular response (systematic and early) after graft between patients controlling or not BKv infection are necessary to improve the comprehension of illness natural history.
The investigators propose to enlarge the investigation of anti-BKv immune cellular response to other functions than IFNg synthesis in the aim of detecting the eventual role of polyfunctional lymphocytes for infection control. Furthermore, the investigators propose to identify better diagnostic and prognostic makers.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Nantes, Frankrijk, 44000
- Nantes' Univeristy hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Kidney-transplanted patient, since less than 30 days
- Older than 18 years old
- Treatment with tacrolimus and mycophénolate mofetil
Exclusion Criteria:
- No informed consent
- Pregnant women
- Patient under legal guardianship
- Treated by ciclosporin or mTOR-inhibitor
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
kidney-transplanted patients
|
blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Comparison of the level of response between patient with a "non-controlled infection" and patients for who the blood viral load is under 103 copBKv/ml.
Tijdsspanne: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
|
Analyse the role of T-lymphocytes response in the control of BKv infection
|
at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/ml
Tijdsspanne: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
|
Other causes for abnormal viremia
|
at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
|
|
Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft
Tijdsspanne: at 12 months after kidney transplantation
|
Determine the frequence of occurence of nephropathy due to BKv for the population with a non-controlled infection
|
at 12 months after kidney transplantation
|
|
Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infection
Tijdsspanne: at 1, 3 et 6 months after modification of immunosuppressive treatment
|
Comparision between the level of immune response and the time when the first viremia is higher than 103 copBKv/ml and 1, 3 et 6 months after modification of immunosuppressive treatment.
|
at 1, 3 et 6 months after modification of immunosuppressive treatment
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- BRD/10/03-ZF
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .