Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

The aim of this observational study is to characterize the urinary replication of BK polyomavirus (BKV) in kidney transplant recipients. Although BKV reactivation after transplantation is well established, the origin of the replicating virus remains uncertain. Current evidence suggests that BKV detected in recipients may originate either from the transplanted kidney (donor-derived) or from viral reactivation in the recipient. The evaluation of new biomarkers to predict BKV replication are needed.

This study seeks to address the following key questions:

* Origin of the replicating virus: Is the BKV detected in the recipient identical to the virus originating from the donor kidney? * Host immune response and viral genotype: Is there an association between the recipient's immune response and the genotype of the replicating BKV? * Differences in immune response according to viral replication profile: Does the immune response differ between patients presenting isolated BKV viruria and those with both viruria and viremia? * Can new biomarkers help predict BKV replication and viremia?

Patients will be grouped according to their BKV replication profile:

Group 1: patients with BKV viruria without viremia Group 2: patients with both BKV viruria and viremia Comparisons between these two groups will help identify whether different viral genotypes or immune responses are associated with systemic dissemination (viremia).

Kidney transplant recipients will be included if they present BKV viruria during their post-transplant follow-up. Additional blood samples will be collected during scheduled follow-up visits at the university hospital. These visits are part of routine clinical care, and no extra visits will be required specifically for the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Kidney transplant patients with a first positive BK virus viral load in urine. - BK virus viral load in urine > 3 log copies/mL.

More than 3 months post-transplant and less than 2 years post-transplant.

Men or women aged 18 years and older.

Followed up at Grenoble Alpes University Hospital.

Disqualifiers

Expected renal graft survival is < 6 months, estimated by an eGFR < 15 mL/min/1.73 m² at the time of BKPyV viruria

Patients who object to the use of their data and/or samples for research purposes

Subjects who are excluded from another study

Subjects under administrative or judicial supervision

Trial population

Kidney transplant patients with a first positive BK virus viral load in urine during the 2 years after the graft

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

To describe the prevalence and variability of different BKPyV genotypes and serotypes in a population of kidney transplant patients with BKPyV viruria/viremia.

The primary endpoint will be the classification by genotyping/serotyping of BKPyV obtained during the first viruria and the first viremia, performed using NGS and serotyping using a seroneutralization technique. The search for SNPs (single nucleotide polymorphisms) will also enable the subclassification of genotypes and better identification of patients at risk of BKPyV viremia and therefore BKPyV-induced nephropathy.

Time frame
up to 2 years

Secondary outcomes

1

Compare the viral genotype at the first viruria/viremia with the donor serotype and with the recipient serotype.

The donor serotype and recipient serotype will be obtained by seroneutralization (from I to IV) and the viral genotype at the first viremia and first viruria will be obtained by a complete sequencing technique (NGS).

Time frame
up to 2 years
2

Describe the evolution of urinary BKPyV viral load during infection and compare viruria between viruric-only and viremic patients.

The urinary viral load for BKPyV will be obtained by qPCR (R-Gene) and expressed in log IU/mL at the time of inclusion in the two groups and then up to 6 months post-inclusion.

Time frame
up to 2 years
3

Describe associations between urinary and blood BKPyV viral load and associated genotypes/the presence of a mismatch between the donor serotype and the recipient genotype.

Urinary viral load at inclusion and at the time of viremia (qPCR R-Gene technique in log IU/mL) and serotype mismatch obtained from serological data at the time of transplantation.

Time frame
up to 2 years
4

Describe the associations between the waiting time until the first viremia and the presence or absence of a serotype mismatch at the time of transplantation, the genotype at the time of the first viruria, the viral load at the time of the first viruria,

The time will be recorded in days between the first post-transplant viruria and viremia.

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.