Prediction of BK Virus Reactivation in Kidney Transplant Recipient

Prediction of BK Virus Infection by Flow Cytometric Analysis of BK Virus-specific T Cell Responses in Kidney Transplant Recipients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06219616

Enrollment

Registered

2024-01-23

Start date

2023-05-01

Completion date

2025-05-31

Last updated

2025-12-31

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

Conditions

BK Virus Infection, BK Virus Nephropathy, Kidney Transplant Infection

Brief summary

There has been no effective predicting tool to accurately predict BKV reactivation after kidney transplantation. The aim is to elucidate the use of flow cytometric analysis for both intracellular cytokines and surface activation markers for BKV-specific T cell response in kidney transplant recipients.

Interventions

DIAGNOSTIC_TESTBKV immune monitoring

Blood will be drawn and investigated for BKV-specific T cell response.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Intervention model description

Every kidney transplant recipient will be tested for BKV-specific immune response after transplantation to identify the potential immune predicting tool for developing BKV reactivation.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. New kidney transplantation cases (either living donor or deceased donor transplantation) 2. Age ≥ 18 years old 3. Agree to give a permission to blood sampling post-transplantation, and at the time of BK viremia.

Exclusion criteria

1. Pregnant 2. Primary non-function of kidney allograft (i.e. kidney allograft never function).

Design outcomes

Primary

Measure	Time frame	Description
BKV-specific immune response	Day 30, Day 90 after transplantation before BK viremia	\- To examine the capability of flow cytometry in predicting post-kidney transplant BKV infection, by the analyses of intracellular cytokines (interleukine-2) and surface activation markers (CD25) of T cells

Secondary

Measure	Time frame	Description
Dynamic change of BKV-specific immune response	Day 30, Day 90 after transplantation, irrespective ly to BK viremia	To examine the chonological change of BKV-specific immune response after transplantation, by the analyses of intracellular cytokines (interleukine-2) and surface activation markers (CD25) of T cells.
BKV-specific immune response and immunosuppression regimen	Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications	To examine the association between immunosuppressive regimen (tacrolimus, cyclosporine A, mycophenolate) and BKV-specific immune response after transplantation, by the analyses of intracellular cytokines (interleukine-2) and surface activation markers (CD25) of T cells.

Countries

Thailand

Outcome results

None listed

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