Prediction of BK Virus Reactivation in Kidney Transplant Recipient

NCT06219616 | Completed DMC

• 1 other identifier: BKV-KCMH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Infection; BK Virus Infection; BK Virus Nephropathy

Outcome Measures

Primary Outcomes (1)

• BKV-specific immune response

  \- 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

  Day 30, Day 90 after transplantation before BK viremia

Secondary Outcomes (2)

• Dynamic change of BKV-specific immune response

  Day 30, Day 90 after transplantation, irrespective ly to BK viremia

• BKV-specific immune response and immunosuppression regimen

  Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications

Study Arms (1)

BKV immune monitoring

OTHER

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.

Diagnostic Test: BKV immune monitoring

Interventions

BKV immune monitoring DIAGNOSTIC_TEST

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

BKV immune monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 23, 2024
• Study Start: May 1, 2023
• Primary Completion: March 30, 2025
• Study Completion: May 31, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-03

Locations

TH (1)