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

NCT04506060 | Unknown

• 1 other identifier: PI2020_843_0101
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

BK Virus Nephropathy; Risk Factor; Kidney Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

serum withdrawal OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

Central Study Contacts

Etienne Brochot, MD

CONTACT

(33)322087064; brochot.etienne@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)