Anti-BK Virus Immune Response and Kidney Transplantation

NCT01109186 | Completed

• 1 other identifier: BRD/10/03-ZF
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

patient with a kidney transplantation since less than 30 days

Outcome Measures

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.

  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

Secondary Outcomes (3)

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

  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

  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

  at 1, 3 et 6 months after modification of immunosuppressive treatment

Study Arms (1)

kidney-transplanted patients

Other: biological parameters

Interventions

biological parameters OTHER

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

kidney-transplanted patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney-transplanted person

You may qualify if:

• Kidney-transplanted patient, since less than 30 days
• Older than 18 years old
• Treatment with tacrolimus and mycophénolate mofetil

You may not qualify if:

• No informed consent
• Pregnant women
• Patient under legal guardianship
• Treated by ciclosporin or mTOR-inhibitor

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes' Univeristy hospital

Nantes, 44000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: November 30, 2010
• Primary Completion: August 26, 2014
• Study Completion: September 1, 2015
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

FR (1)