Salivary Replication of BK Virus in Post-kidney Transplant

NCT ID: NCT07256470

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

Salivary self-collection

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• kidney transplant recipients
• age ≥ 18 years

Exclusion Criteria

• age < 18 years
• absence of consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Countries

France

Central Contacts

Ophélie Fourdinier, MD

Role: CONTACT

fourdrinier.ophelie@chu-amiens.fr

33+03 22 45 58 62

Facility Contacts

Ophelie Fourdrinier, MD

Role: primary

fourdrinier.ophelie@chu-amiens.fr

33+3 22 45 58 62

Other Identifiers

PI2024_843_0093

Identifier Type: -

Identifier Source: org_study_id