Usefulness of BK virus-specific interferon-γ enzyme-linked immunospot assay for predicting the outcome of BK virus infection in kidney transplant recipients.
Hyunjoo Bae, Do Hyun Na, Ji-Yeun Chang...
https://pubmed.ncbi.nlm.nih.gov/32241081Actively Recruiting
Age: 18Years +
All Genders
ID07347769
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
Led by University Hospital, Grenoble · Updated on 2026-05-27
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the BK polyomavirus (BKV) in kidney transplant recipients, focusing on understanding the source of the virus when it replicates in the urinary tract. The study aims to determine if the BKV detected in patients comes from the donor kidney or from the recipient's own viral reactivation. It also explores how the immune response relates to the virus's genotype and whether new biomarkers can help predict viral replication and spread in the body. This observational study groups patients based on their BKV replication profile: those with virus only in urine (viruria) and those with virus in both urine and blood (viremia). Kidney transplant recipients with BKV viruria during routine follow-up at the university hospital are included. No extra visits are required beyond standard clinical care, and additional blood samples will be collected during these scheduled visits to analyze viral and immune markers. Participants will be monitored up to two years, with researchers measuring the prevalence and types of BKV genotypes and serotypes, comparing viral loads, immune responses, and the presence of viral microRNAs and chemokines. The study evaluates associations between viral characteristics and immune function, as well as the impact of immunosuppressive treatments. Safety and kidney function are followed through routine clinical assessments during this period.
CONDITIONS
Brief Title
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Kidney transplant patients with a first positive BK virus viral load in urine greater than 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 will not qualify if you...
- Expected renal graft survival less than 6 months, estimated by an eGFR below 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants who have a first positive BK virus viral load in urine are observed to describe the prevalence and variability of different BKPyV genotypes and serotypes, and to monitor viral loads and immune responses over time.
Visits scheduled over 2 years to monitor viral load and immune response
Trial Site Locations
Total: 1 location
1
CHUGA
Grenoble, France, 38000
Actively Recruiting
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Research Team
A
Aurélie TRUFFOT, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
BK Polyomavirus Micro-RNAs: Time Course and Clinical Relevance in Kidney Transplant Recipients.
Baptiste Demey, Véronique Descamps, Claire Presne...
https://pubmed.ncbi.nlm.nih.gov/33672313Polyomavirus BK with rearranged noncoding control region emerge in vivo in renal transplant patients and increase viral replication and cytopathology.
Rainer Gosert, Christine H Rinaldo, Georg A Funk...
https://pubmed.ncbi.nlm.nih.gov/18347101A systematic review and meta-analysis of enzyme-linked immunosorbent spot (ELISPOT) assay for BK polyomavirus immune response monitoring after kidney transplantation.
Suwasin Udomkarnjananun, Stephen J Kerr, Marith I Francke...
https://pubmed.ncbi.nlm.nih.gov/33979739Neutralizing Antibody-Mediated Response and Risk of BK Virus-Associated Nephropathy.
Morgane Solis, Aurélie Velay, Raphaël Porcher...
https://pubmed.ncbi.nlm.nih.gov/29042457