BK Virus InfectionNCT06538961
Immune Registry for BK in Kidney Transplant Recipients
An observational study of BK Virus Infection and Kidney Transplant; Complications, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus Infection, Kidney Transplant; Complications
- What is being tested?
- Blood samples: Main Study group, Data Collection and Urine Sample- Main Study group
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to Jul 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study will include adults 18 and older who have undergone single organ deceased donor Kidney Transplant.
Who may be able to join
- Adult (>18 years old) male and female, deceased donor KT recipients
- Will include single organ transplants.
- Each participant must also have recently been diagnosed with BK viremia.
- In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab).
Who cannot join
- Prisoners will not be included in the study
- Multi-organ transplants and pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Ambreen Azhar, 804-828-4104, ambreen.azhar@vcuhealth.org
Gelila Abebe, 804-628-4969, gelila.abebe@vcuhealth.org
About this study
Official title: Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.
Read the detailed description
As with other viral infections, adaptive immunity plays an essential role in the control of BK virus infection. Previous studies have shown that humoral immunity doesn't prevent viral reactivation and cellular responses including CD4+ and CD8+ T cells play a crucial role in containing viral replication. Researchers have investigated the role of reconstitution of BK-specific T cell immunity KT recipients with overall low immunological risk populations showing that pre and post-transplant BK virus-specific cellular responses can be used as an important tool to identify KT recipients at increased risk of developing BK virus infection in the first year post-transplant. We plan to understand the role of adaptive immunity (cellular and humoral interplay) in a cohort with at least 50% of high immunological KT recipients with predominantly retransplant candidates, highly sensitized recipients with calculated panel reactive antibodies > 40 %, positive crossmatch or history of prior desensitization therapies.
The aim includes the sequential demonstration of immunogenesis processes that are specific to the BK virus in individuals who experience BK viremia and undergo various treatment approaches such as immunosuppression reduction and immune enhancement through intravenous immunoglobulins (IVIG).
- Being tested
- Blood samples: Main Study group, Data Collection, Urine Sample- Main Study group, Urine sample- Sub-study group, Blood sample: Sub-study group
- Keywords
- Immune Registry, BK in Kidney Transplant Recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples: Main Study groupOther
the collection of blood samples at specified time points.
Data CollectionOther
Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.
Urine Sample- Main Study groupOther
-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects
Urine sample- Sub-study groupOther
- Post-transplant monthly urine sample collection for 6 months in all subjects
Blood sample: Sub-study groupOther
Monthly blood sample collection for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Main study | Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant. Receives: Other: Blood samples: Main Study group; Other: Data Collection; Other: Urine Sample- Main Study group | |
| Sub-study | Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia or those with difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant. Receives: Other: Data Collection; Other: Urine sample- Sub-study group; Other: Blood sample: Sub-study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus
Assessing the effect of kidney transplant induction and maintenance triple immunosuppression on humoral and cellular responses against BK virus compared at pre- and post-KT through clinical chart review, abnormal value or result from a clinical or laboratory evaluation, by assessing humoral and cellular responses against BK virus through BK specific T cell response, immunoglobulin G targeting BK levels, urine gene expression test to detect for BK virus and rejection.
Measured: 24 months
Secondary outcomes (1)
To identify the frequency risk of BK viremia
To identify the frequency risk of BK viremia post-transplant with careful monitoring of cellular and humoral responses against BK measured using BKV T cell immunity panel test, BKV IgG test, uromap(urine gene expression test to detect for BK virus and rejection), clinical chart review and abnormal values or results from a clinical laboratory evaluation including BKV PCR.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start29 May 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK Virus InfectionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins
- Responsible party
- Sponsor
- Investigators
- Ambreen Azhar, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538961
- Sponsor's protocol ID
- HM20028057
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06538961
- Acronym / sponsor ID
- HM20028057
- Keywords
- Immune Registry, BK in Kidney Transplant Recipients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eurofins
- Study start
- 29 May 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Aug 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.
Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.
Detailed description
As with other viral infections, adaptive immunity plays an essential role in the control of BK virus infection. Previous studies have shown that humoral immunity doesn't prevent viral reactivation and cellular responses including CD4+ and CD8+ T cells play a crucial role in containing viral replication. Researchers have investigated the role of reconstitution of BK-specific T cell immunity KT recipients with overall low immunological risk populations showing that pre and post-transplant BK virus-specific cellular responses can be used as an important tool to identify KT recipients at increased risk of developing BK virus infection in the first year post-transplant. We plan to understand the role of adaptive immunity (cellular and humoral interplay) in a cohort with at least 50% of high immunological KT recipients with predominantly retransplant candidates, highly sensitized recipients with calculated panel reactive antibodies > 40 %, positive crossmatch or history of prior desensitization therapies.
The aim includes the sequential demonstration of immunogenesis processes that are specific to the BK virus in individuals who experience BK viremia and undergo various treatment approaches such as immunosuppression reduction and immune enhancement through intravenous immunoglobulins (IVIG).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main study | – | Other: Blood samples: Main Study group, Other: Data Collection, Other: Urine Sample- Main Study groupSingle organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant. |
| Sub-study | – | Other: Data Collection, Other: Urine sample- Sub-study group, Other: Blood sample: Sub-study groupSingle organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia or those with difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adults 18 and older who have undergone single organ deceased donor Kidney Transplant.
Key inclusion criteria (4 listed)
- Adult (>18 years old) male and female, deceased donor KT recipients
- Will include single organ transplants.
- Each participant must also have recently been diagnosed with BK viremia.
- In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab).
Key exclusion criteria (2 listed)
- Prisoners will not be included in the study
- Multi-organ transplants and pregnant women
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 |
|---|---|---|
| Blood samples: Main Study groupthe collection of blood samples at specified time points. | Other | Main study |
| Data CollectionDonor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging. | Other | Main study, Sub-study |
| Urine Sample- Main Study group-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects | Other | Main study |
| Urine sample- Sub-study group- Post-transplant monthly urine sample collection for 6 months in all subjects | Other | Sub-study |
| Blood sample: Sub-study groupMonthly blood sample collection for 6 months | Other | Sub-study |
Primary outcome
Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus
Time frame: 24 months
Assessing the effect of kidney transplant induction and maintenance triple immunosuppression on humoral and cellular responses against BK virus compared at pre- and post-KT through clinical chart review, abnormal value or result from a clinical or laboratory evaluation, by assessing humoral and cellular responses against BK virus through BK specific T cell response, immunoglobulin G targeting BK levels, urine gene expression test to detect for BK virus and rejection.
1 secondary outcome
To identify the frequency risk of BK viremia
Time frame: 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for BK Virus Infection
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Kidney Diseases, Kidney Injury
Active, not recruitingPhase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection
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.
Ambreen Azhar principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BK Virus Infection and Kidney Transplant; Complications, run by Virginia Commonwealth University at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ambreen Azhar (804-828-4104, ambreen.azhar@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus (time frame: 24 months). 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 20 Aug 2026.