Prediction of BK Virus Reactivation in Kidney Transplant Recipient

King Chulalongkorn Memorial Hospital

Status: Completed

Conditions: BK Virus Nephropathy; Kidney Transplant Infection; BK Virus Infection

Treatments: Diagnostic Test: BKV immune monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06219616

BKV-KCMH

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

BKV immune monitoring

Other group

Description:

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.

Treatment:

Diagnostic Test: BKV immune monitoring