Kidney Transplant InfectionNCT06219616
Prediction of BK Virus Reactivation in Kidney Transplant Recipient
A study testing BKV immune monitoring in people with Kidney Transplant Infection and BK Virus Infection, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection, BK Virus Infection, BK Virus Nephropathy
- What is being tested?
- BKV immune monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant
- Primary non-function of kidney allograft (i.e. kidney allograft never function).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of BK Virus Infection by Flow Cytometric Analysis of BK Virus-specific T Cell Responses in Kidney Transplant Recipients
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.
- Being tested
- BKV immune monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKV immune monitoringDiagnostic test
Blood will be drawn and investigated for BKV-specific T cell response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: BKV immune monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 30, Day 90 after transplantation before BK viremia
Secondary outcomes (2)
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.
Measured: Day 30, Day 90 after transplantation, irrespective ly to BK viremia
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.
Measured: Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 May 2023
- Primary completion30 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwasin Udomkarnjananun, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219616
- Sponsor's protocol ID
- BKV-KCMH
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of BK Virus Infection by Flow Cytometric Analysis of BK Virus-specific T Cell Responses in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06219616
- Acronym / sponsor ID
- BKV-KCMH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BKV immune monitoring | Other | Diagnostic Test: BKV immune monitoring1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant
- Primary non-function of kidney allograft (i.e. kidney allograft never function).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKV immune monitoringBlood will be drawn and investigated for BKV-specific T cell response. | Diagnostic test | BKV immune monitoring |
Primary outcome
BKV-specific immune response
Time frame: 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
2 secondary outcomes
Dynamic change of BKV-specific immune response
Time frame: Day 30, Day 90 after transplantation, irrespective ly to BK viremia
BKV-specific immune response and immunosuppression regimen
Time frame: Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BKV immune monitoring in people with Kidney Transplant Infection and BK Virus Infection, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BKV-specific immune response (time frame: Day 30, Day 90 after transplantation before BK viremia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.