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Anti-BK Virus Immune Response and Kidney Transplantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01109186
Acronym
BKv
Enrollment
158
Registered
2010-04-23
Start date
2010-11-30
Completion date
2015-09-01
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

patient with a kidney transplantation since less than 30 days

Brief summary

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.

Interventions

blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantationAnalyse the role of T-lymphocytes response in the control of BKv infection

Secondary

MeasureTime frameDescription
Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/mlat 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantationOther causes for abnormal viremia
Measurement of histological consequences of a BKv non-controlled infection during the first year post-graftat 12 months after kidney transplantationDetermine the frequence of occurence of nephropathy due to BKv for the population with a non-controlled infection
Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infectionat 1, 3 et 6 months after modification of immunosuppressive treatmentComparision 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026