Prediction of BK Virus Reactivation in Kidney Transplant Recipient

Kidney Transplant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06219616
• Other study ID #: BKV-KCMH
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: January 2024
• Source: King Chulalongkorn Memorial Hospital
• Contact: Suwasin Udomkarnjananun
• Phone: 6622564000
• Email: suwasin.u[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• BK Virus Infection
• BK Virus Nephropathy
• Communicable Diseases
• Infections
• Kidney Transplant Infection
• Virus Diseases

Intervention

Diagnostic Test:
• BKV immune monitoring
Blood will be drawn and investigated for BKV-specific T cell response.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dynamic change of BKV-specific immune response	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.	Day 30, Day 90 after transplantation, irrespective ly to BK viremia
Secondary	BKV-specific immune response and immunosuppression regimen	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.	Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications