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Not yet recruiting NCT07256470

Salivary Replication of BK Virus in Post-kidney Transplant

No phase Interventional BK Virus Salivary Replication Kidney Transplantation Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Salivary self-collection.
Who it may be relevant to
Registry conditions: BK Virus, Salivary Replication, Kidney Transplantation, Nephropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Number of BK positive saliva and blood samples [Time frame: 12 months]
Secondary outcome measures (3)
  • urinary BK virus concentration [Time frame: 12 months]
  • variation of BK virus genome [Time frame: 12 months]
  • Immunoglobin concentrations [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • kidney transplant recipients
  • age ≥ 18 years

Exclusion criteria

  • age < 18 years
  • absence of consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Identifiers

NCT: NCT07256470 · PI2024_843_0093

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗