NCT07347769 Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
| NCT ID | NCT07347769 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Nephropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2028-09-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-03-11 with a primary completion date of 2028-09-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Aurélie TRUFFOT
PRINCIPAL INVESTIGATOR
CHUGA
Frequently Asked Questions
Who can join the NCT07347769 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07347769 currently recruiting?
Yes, NCT07347769 is actively recruiting participants. Contact the research team at atruffot@chu-grenoble.fr for enrollment information.
Where is the NCT07347769 trial being conducted?
This trial is being conducted at Grenoble, France.
Who is sponsoring the NCT07347769 clinical trial?
NCT07347769 is sponsored by University Hospital, Grenoble. The principal investigator is Aurélie TRUFFOT at CHUGA. The trial plans to enroll 100 participants.