Immune Registry for BK in Kidney Transplant Recipients
NCT Number: NCT06538961
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: BK Virus Infection|Kidney Transplant; Complications
Interventions: OTHER: Collection of blood samples|OTHER: Data Collection|OTHER: Urine Sample
Sponsor: Virginia Commonwealth University
Collaborators: Eurofins
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-29
Completion Date: 2026-05
Locations: Virginia Commonwealth University, Richmond, Virginia, 23298, United States

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.

Primary Outcome Measures: 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, The effect of kidney transplant induction and maintenance triple immunosuppression on humoral and cellular responses against BK virus compared at pre and post-KT assessing:

* Effects of kidney transplant immunosuppression therapy on humoral and cellular response against BK virus.
* Humoral and cellular responses against BK virus compared at Pre-and post-KT

Measured by:

* assessing effect of kidney transplant induction and maintenance triple immunosuppression through clinical chart review and abnormal value or result from a clinical or laboratory evaluation
* 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, clinical chart review and abnormal values or results from a clinical laboratory evaluation, 24 months
Secondary Outcome Measures: To identify the frequency risk of BK viremia with careful monitoring of cellular and humoral responses against BK, To identify the frequency risk of BK viremia with careful monitoring of cellular and humoral responses against BK assessing :

-frequency of BK viremia post-transplant.

Measured by:

Viremia frequency is assessed through 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., 24 month