Salivary Replication of BK Virus in Post-kidney Transplant

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07256470

Acronym

BKSAL

Enrollment

100

Registered

2025-12-01

Start date

2025-12-31

Completion date

2028-06-30

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BK Virus, DNAemia, Kidney Transplantation, Nephropathy, Salivary Replication

Keywords

BK virus, salivary replication, kidney transplantation, nephropathy, DNAemia

Brief summary

BK virus infection in kidney transplantation can compromise graft function. Current data suggest that BK virus nephropathy results not only from transmission of virus from the donor but also from reactivation of latent virus in the recipient. However, no study has investigated the possibility of respiratory transmission. This study would provide a better understanding of the pathophysiology of BK virus infection in kidney transplant recipients. The investigators would study viral replication of BK virus in saliva, urine and blood of patients who received a kidney transplant at the Amiens University Hospital. For this, the investigators will collect salivary self-collection on the day of the kidney transplant then at 1, 3, 6, 9 and 12 months as well as a urine and blood sample. The investigators will measure BK viral load in these three samples at different times.

Interventions

BIOLOGICALSalivary self-collection

Salivary self-collection on the day of the kidney transplant then at 1, 3, 6, 9 and 12 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* kidney transplant recipients * age ≥ 18 years

Exclusion criteria

* age \< 18 years * absence of consent

Design outcomes

Primary

Measure	Time frame	Description
Number of BK positive saliva and blood samples	12 months	Compare the positivity of the BK virus viral load between the saliva sample and the urine and blood samples

Secondary

Measure	Time frame	Description
urinary BK virus concentration	12 months	—
variation of BK virus genome	12 months	variation of BK virus genome in different samples
Immunoglobin concentrations	12 months	Immunoglobin concentrations in different samples

Countries

France

Contacts

Primary ContactOphélie Fourdinier, MD

fourdrinier.ophelie@chu-amiens.fr33+03 22 45 58 62

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026