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

NCT ID: NCT04506060

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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BK Virus Nephropathy Risk Factor Kidney Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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serum 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Etienne Brochot, MD

Role: CONTACT

(33)322087064

Facility Contacts

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Etienne Brochot, MD

Role: primary

(33)322087064

Etienne Brochot

Role: backup

(33)322087064

Other Identifiers

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PI2020_843_0101

Identifier Type: -

Identifier Source: org_study_id

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