Prediction of BK Virus Reactivation in Kidney Transplant Recipient

Not Applicable

Recruiting

• Conditions: Kidney Transplant Infection; BK Virus Infection; BK Virus Nephropathy
• Interventions: Diagnostic Test: BKV immune monitoring

• Registration Number: NCT06219616
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-10-30
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BKV immune monitoring	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand