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.
Studieoversikt
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Nantes, Frankrike, 44000
- Nantes' Univeristy hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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kidney-transplanted patients
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blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
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Analyse the role of T-lymphocytes response in the control of BKv infection
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at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/ml
Tidsramme: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
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Other causes for abnormal viremia
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at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
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Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft
Tidsramme: at 12 months after kidney transplantation
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Determine the frequence of occurence of nephropathy due to BKv for the population with a non-controlled infection
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at 12 months after kidney transplantation
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Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infection
Tidsramme: at 1, 3 et 6 months after modification of immunosuppressive treatment
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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.
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at 1, 3 et 6 months after modification of immunosuppressive treatment
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- BRD/10/03-ZF
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