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

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 Overview

• Status: Recruiting
• Conditions: Kidney Transplantation; Risk Factor; BK Virus Nephropathy
• Intervention / Treatment: Other: serum withdrawal

• Study Type: Observational
• Enrollment (Anticipated): 378

Contacts and Locations

• Study Contact: Name: Etienne Brochot, MD; Phone Number: (33)322087064; Email: brochot.etienne@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Contact: Etienne Brochot, MD; Phone Number: (33)322087064; Email: brochot.etienne@chu-amiens.fr
    • Contact: Etienne Brochot; Phone Number: (33)322087064; Email: brochot.etienne@chu-amiens.fr
    • Sub-Investigator: Maité Jaureguy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: kidney transplantation; risk factor; BK Virus Nephropathy; viral serology
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: PI2020_843_0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No