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NCT Number: NCT01109186

Anti-BK Virus Immune Response and 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes' Univeristy hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological parameters

Other

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

Primary outcomes

  1. 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.

    Time frame: 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

Secondary outcomes

  1. Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/ml

    Time frame: at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation

    Other causes for abnormal viremia

  2. Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft

    Time frame: at 12 months after kidney transplantation

    Determine the frequence of occurence of nephropathy due to BKv for the population with a non-controlled infection

  3. Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: BKv

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Apr 23, 2010
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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