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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04506060

Acronym

BKSEREIN

Enrollment

378

Registered

2020-08-10

Start date

2020-09-01

Completion date

2022-09-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BK Virus Nephropathy, Kidney Transplantation, Risk Factor

Keywords

BK Virus Nephropathy, risk factor, kidney transplantation, viral serology

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.

Interventions

OTHERserum withdrawal

Serum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026