Status:
NOT_YET_RECRUITING
Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
BK Polyomavirus
Kidney Transplant
Eligibility:
All Genders
7+ years
Brief Summary
The human pathogen BK polyomavirus (BKPyV) is a ubiquitous, small, non-enveloped DNA virus that infects over 90% of people, typically in childhood with mild or no symptoms. Following primary infection...
Eligibility Criteria
Inclusion
- 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
- Objection to participation in the research study
Key Trial Info
Start Date :
May 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06988072
Start Date
May 30 2025
End Date
May 30 2028
Last Update
May 23 2025
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