Anti-BK Virus Immune Response and Kidney Transplantation (BKv)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01109186
First received: April 21, 2010
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Kidney Transplantation
Other: biological parameters

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Analyse the role of T-lymphocytes response in the control of BKv infection


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Other causes for abnormal viremia

  • Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft [ Time Frame: at 12 months after kidney transplantation ] [ Designated as safety issue: No ]
    Determine 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 infection [ Time Frame: at 1, 3 et 6 months after modification of immunosuppressive treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
kidney-transplanted patients Other: biological parameters
blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Kidney-transplanted person

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109186

Contacts
Contact: Celin Bressollette, MD 02.40.08.41.22 celine.bressollette@chu-nantes.fr

Locations
France
Nantes' Univeristy hospital Recruiting
Nantes, France, 44000
Contact: Celine Bressollette, MD    02.40.08.41.22    celine.bressollette@chu-nantes.fr   
Principal Investigator: Celine Bressollette, MD         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01109186     History of Changes
Other Study ID Numbers: BRD 10/3-ZF
Study First Received: April 21, 2010
Last Updated: November 16, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by Nantes University Hospital:
patient with a kidney transplantation since less than 30 days

ClinicalTrials.gov processed this record on September 16, 2014