Salivary Replication of BK Virus in Post-kidney Transplant

NCT07256470 | Not Yet Recruiting DMC

• 1 other identifier: PI2024_843_0093
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of BK positive saliva and blood samples

  Compare the positivity of the BK virus viral load between the saliva sample and the urine and blood samples

  12 months

Secondary Outcomes (3)

• urinary BK virus concentration

  12 months

• variation of BK virus genome

  12 months

• Immunoglobin concentrations

  12 months

Interventions

Salivary self-collection BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kidney transplant recipients
• age ≥ 18 years

You may not qualify if:

• age \< 18 years
• absence of consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Ophélie Fourdinier, MD

CONTACT

33+03 22 45 58 62; fourdrinier.ophelie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)