Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nephropathy, Opportunistic Viral Infection, Polyoma Virus Nephropathy, BK Nephropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- To describe the prevalence and variability of different BKPyV genotypes and serotypes in a population of kidney transplant patients with BKPyV viruria/viremia. [Time frame: up to 2 years]
Secondary outcome measures (12)
- Compare the viral genotype at the first viruria/viremia with the donor serotype and with the recipient serotype. [Time frame: up to 2 years]
- Describe the evolution of urinary BKPyV viral load during infection and compare viruria between viruric-only and viremic patients. [Time frame: 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. [Time frame: 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, [Time frame: 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. [Time frame: up to 2 years]
- Describe the link between the functional response and the presence of viremia, the evolution of the BKPyV viral load in the blood, and the genotype. [Time frame: up to 2 years]
- Compare the BKPyV genotype present in the renal biopsy at M3 with the urinary replicative genotype at inclusion and the donor serotype. [Time frame: up to 2 years]
- Quantitatively describe the presence of BKPyV microRNAs in urine and compare the two groups (viremic and viruric alone). [Time frame: up to two years]
- Describe the link between the quantity of BKPyV microRNAs and the replicative genotype. [Time frame: up to 2 years]
- Quantitatively describe the presence of urinary chemokines and compare the two groups (viremic and viruric alone). [Time frame: up to 2 years]
- Describe the link between the quantity of B-KPyV chemokines at inclusion and the replicative genotype. [Time frame: up to 2 years]
- Monitor the number of BKV viruria or viremia depending on the immunosuppressive treatment received. [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHUGA — Grenoble
Publications
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07347769 · 38RC24.0247 · 2025-A02381-48