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Clinical Trials/NCT04506060
NCT04506060CompletedNot Applicable

Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

Centre Hospitalier Universitaire, Amiens1 site in 1 country378 target enrollmentStarted: September 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
378
Locations
1
Primary Endpoint
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient

Study Overview

Brief Summary

Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •adult kidney transplanted patients
  • •Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation.

Exclusion Criteria

  • •Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)

Outcomes

Primary Outcomes

Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient

Time Frame: one year

Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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