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NCT Number: NCT07256470

Salivary Replication of BK Virus in Post-kidney Transplant

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.

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Key information

Conditions

BK Virus DNAemia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Transplantation Male Urogenital Diseases Nephropathy Salivary Replication Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location contact

Ophelie Fourdrinier, MD

CONTACT

[email protected]

33+3 22 45 58 62

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • kidney transplant recipients
  • age ≥ 18 years

Exclusion criteria

  • age < 18 years
  • absence of consent

Treatment and study plan

Salivary self-collection

Biological

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

Primary outcomes

  1. Number of BK positive saliva and blood samples

    Time frame: 12 months

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

Secondary outcomes

  1. urinary BK virus concentration

    Time frame: 12 months

  2. variation of BK virus genome

    Time frame: 12 months

    variation of BK virus genome in different samples

  3. Immunoglobin concentrations

    Time frame: 12 months

    Immunoglobin concentrations in different samples

Study contacts

Contact information is provided by the study sponsor or research team.

Ophélie Fourdinier, MD

CONTACT

[email protected]

33+03 22 45 58 62

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: BKSAL

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 1, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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