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Immune Registry for BK in Kidney Transplant Recipients
Sponsor: Virginia Commonwealth University
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. 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.
Official title: Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2024-05-29
Completion Date
2026-05
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Blood samples: Main Study group
the collection of blood samples at specified time points.
Data Collection
Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.
Urine Sample- Main Study group
-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects
Urine sample- Sub-study group
\- Post-transplant monthly urine sample collection for 6 months in all subjects
Blood sample: Sub-study group
Monthly blood sample collection for 6 months
Locations (1)
Virginia Commonwealth University
Richmond, Virginia, United States