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Prediction of BK Virus Reactivation in Kidney Transplant Recipient

NCT ID: NCT06219616

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Infection BK Virus Infection BK Virus Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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BKV immune monitoring

1. In this prospective cohort, the included kidney transplant recipients will receive regular post-transplantation care, including routine therapeutic drug monitoring of tacrolimus and screening for BK viremia. No extra medications beyond the standard of care will be given to the patients in this study.
2. Whole blood will be drawn from kidney transplant recipients on day 30, day 180, and at the time of BK viremia. PBMCs will be separated and incubated with BK viral peptides.
3. PBMCs will be stained for surface marker of activated T cells and intracellular cytokines 4. Phenotypic features of T cells will be analyzed under flow cytometry and correlated with the occurrence of BKV infection and immunosuppressive medications.

Group Type OTHER

BKV immune monitoring

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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BKV immune monitoring

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Chulalongkorn Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Suwasin Udomkarnjananun

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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BKV-KCMH

Identifier Type: -

Identifier Source: org_study_id