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NCT Number: NCT06219616

Prediction of BK Virus Reactivation in Kidney Transplant Recipient

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.

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Key information

Conditions

Kidney Transplant Infection BK Virus Infection BK Virus Nephropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

BKV immune monitoring

Diagnostic Test

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

Primary outcomes

  1. BKV-specific immune response

    Time frame: 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 outcomes

  1. Dynamic change of BKV-specific immune response

    Time frame: 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.

  2. BKV-specific immune response and immunosuppression regimen

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Dec 31, 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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