Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system responds to the BK polyomavirus (BKPyV) in kidney transplant patients who have developed a viral infection known as BKPyV viremia. BKPyV is a common virus that usually doesn’t cause problems in healthy people, but it can lead to serious complications in kidney transplant recipients because their immune systems are weakened by medications meant to prevent organ rejection. The researchers want to learn more about the immune responses that help control this virus, which could help identify patients at risk for complications and improve treatment strategies.

To participate in the trial, individuals must be at least 7 years old and have received a kidney transplant within the last 12 months. They will be grouped based on whether they have detectable BKPyV in their blood or not. Healthy donors aged 18 and older can also participate by donating blood for research. Participants can expect to undergo tests that will help researchers understand how their immune systems are responding to the virus. This knowledge may lead to better monitoring and treatment options for kidney transplant patients in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • No objection to participation in the research study (from patients or legal guardians)
• • Affiliated to the French national social security system
• • Age ≥ 7 years old
• • Weight ≥ 12 kg
• Additional criteria for kidney transplant recipients with BKPyV DNAemia:
• • Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication
• • Detectable de novo BKPyV DNAemia within the first 12 months post-transplantation
• Additional criteria for kidney transplant recipients without BKPyV DNAemia:
• • Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication
• • No detectable de novo BKPyV DNAemia within the first 12 months post-transplantation
• Additional criteria for healthy donors (controls):
• • Age ≥ 18 years old
• • Blood donation to the EFS
• • Consent for the use of their blood donation for research purposes.
• Exclusion Criteria:
• • Objection to participation in the research study