Anti-BK Virus Immune Response and Kidney Transplantation

Kidney Transplantation Clinical Trial

— BKv  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109186
• Other study ID #: BRD/10/03-ZF
• Status: Completed
• Start date: November 30, 2010
• Est. completion date: September 1, 2015

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 1, 2015
• Est. primary completion date: August 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Other:
• biological parameters
blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation

Locations

Country	Name	City	State
France	Nantes' Univeristy hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analyse of the other causes that could influence the occurence of a viremia higher than 103 copBKv/ml	Other causes for abnormal viremia	at 1month, 2months, 3months, 4, 5, 6, 7, 8 and 9 months after kidney transplantation
Secondary	Measurement of histological consequences of a BKv non-controlled infection during the first year post-graft	Determine the frequence of occurence of nephropathy due to BKv for the population with a non-controlled infection	at 12 months after kidney transplantation
Secondary	Measurement of increase of immune response due to modifications of immunosuppressive treatment for patient with a non-controlled infection	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.	at 1, 3 et 6 months after modification of immunosuppressive treatment