Actively Recruiting
Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
Led by Virginia Commonwealth University · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
E
Eurofins
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the immune responses related to BK virus infection in kidney transplant recipients, focusing on the balance between preventing rejection and controlling infection. BK virus nephropathy affects a notable proportion of patients after kidney transplant, leading to complications such as kidney injury, rejection risk, longer hospital stays, and sometimes graft loss. The study aims to clarify how adaptive immunity, particularly cellular responses, controls BK virus in patients with varying immunological risk, including highly sensitized recipients and retransplant candidates. The study includes two groups: the main group of single organ deceased donor kidney transplant recipients enrolled at transplant time, and a sub-study group of recipients diagnosed with BK viremia or difficult-to-treat BK virus infection. Researchers collect blood and urine samples monthly for six months post-transplant to study immune responses and viral activity. Clinical data such as history, labs, and imaging are also gathered to support the research. Participants will be followed for up to 24 months to assess how immunosuppression therapy affects the immune response to BK virus and to identify the frequency and risk of BK viremia. The study involves regular sample collections and clinical evaluations, allowing researchers to monitor immune cell activity and viral dynamics. This observational study does not involve administering treatments but closely follows participants' health and viral status over time.
CONDITIONS
Brief Title
Immune Registry for BK in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old
- Male and female deceased donor kidney transplant recipients
- Single organ kidney transplant recipients
- Diagnosed with BK viremia post-transplant
- Sub-study participants must have BK viremia or difficult-to-treat BK virus with minimal viral load decrease
You will not qualify if you...
- Prisoners
- People who have had multi-organ transplants
- Pregnant women
- Participants not meeting inclusion criteria for BK viremia or transplant type
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants are observed with regular collection of clinical information, blood, and urine samples to monitor BK virus immune response and viral load.
Monthly visits for up to 6 months
Duration - Up to 24 months
Participants are followed to assess the effect of immunosuppression therapy on immune response against BK virus and the frequency risk of BK viremia over 24 months.
Periodic follow-up visits up to 24 months
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
A
Ambreen Azhar
G
Gelila Abebe
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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