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

NCT07347769 | Not Yet Recruiting DMC

• 2 other identifiers: 38RC24.02472025-A02381-48
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephropathy; BK Virus Infection; BK Polyomavirus; Immune Response; Neutralizing Antibodies; Opportunistic Viral Infection; Polyoma Virus Nephropathy; BK Nephropathy; BK Viremia; BKV DNAemia

Keywords

TTV; BK polyomavirus; neutralizing antibodies; ELISPOT BKV; genotype; miRNA BKV; urinary chimiokine

Outcome Measures

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.

  up to 2 years

Secondary Outcomes (14)

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

  up to 2 years

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

  up to 2 years

• 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.

  up to 2 years

• 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,

  up to 2 years

• Compare the evolution of the anti-BKPyV T-cell functional response in patients with viruria alone and those also with viremia between inclusion and 6 months later.

  up to 2 years

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

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

You may qualify if:

• 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.
• Affiliated with social security or beneficiary of such a scheme.
• Patients who are not opposed to the TYPIK study.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHUGA

Grenoble, France, 38000, France

Location

Related Publications (5)

• Bae H, Na DH, Chang JY, Park KH, Min JW, Ko EJ, Lee H, Yang CW, Chung BH, Oh EJ. Usefulness of BK virus-specific interferon-gamma enzyme-linked immunospot assay for predicting the outcome of BK virus infection in kidney transplant recipients. Korean J Intern Med. 2021 Jan;36(1):164-174. doi: 10.3904/kjim.2019.339. Epub 2020 Apr 3.

  PMID: 32241081 BACKGROUND

• Demey B, Descamps V, Presne C, Helle F, Francois C, Duverlie G, Castelain S, Brochot E. BK Polyomavirus Micro-RNAs: Time Course and Clinical Relevance in Kidney Transplant Recipients. Viruses. 2021 Feb 23;13(2):351. doi: 10.3390/v13020351.

  PMID: 33672313 BACKGROUND

• Gosert R, Rinaldo CH, Funk GA, Egli A, Ramos E, Drachenberg CB, Hirsch HH. Polyomavirus BK with rearranged noncoding control region emerge in vivo in renal transplant patients and increase viral replication and cytopathology. J Exp Med. 2008 Apr 14;205(4):841-52. doi: 10.1084/jem.20072097. Epub 2008 Mar 17.

  PMID: 18347101 BACKGROUND

• Udomkarnjananun S, Kerr SJ, Francke MI, Avihingsanon Y, van Besouw NM, Baan CC, Hesselink DA. A systematic review and meta-analysis of enzyme-linked immunosorbent spot (ELISPOT) assay for BK polyomavirus immune response monitoring after kidney transplantation. J Clin Virol. 2021 Jul;140:104848. doi: 10.1016/j.jcv.2021.104848. Epub 2021 Apr 28.

  PMID: 33979739 BACKGROUND

• Solis M, Velay A, Porcher R, Domingo-Calap P, Soulier E, Joly M, Meddeb M, Kack-Kack W, Moulin B, Bahram S, Stoll-Keller F, Barth H, Caillard S, Fafi-Kremer S. Neutralizing Antibody-Mediated Response and Risk of BK Virus-Associated Nephropathy. J Am Soc Nephrol. 2018 Jan;29(1):326-334. doi: 10.1681/ASN.2017050532. Epub 2017 Oct 17.

  PMID: 29042457 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We will retained plasma, whole blood and urine.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Aurélie TRUFFOT

  CHUGA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie TRUFFOT, PHD

CONTACT

0786498337; atruffot@chu-grenoble.fr

Study Design

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

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): January 15, 2030
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)