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BK Virus InfectionKidney and urinaryImmune and autoimmune

What this study is

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.

What's being tested

  • Blood samples: Main Study group

    Intervention · OTHER

    the collection of blood samples at specified time points.

  • Data Collection

    Intervention · OTHER

    Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.

  • Urine Sample- Main Study group

    Intervention · OTHER

    -Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects

  • Urine sample- Sub-study group

    Intervention · OTHER

    - Post-transplant monthly urine sample collection for 6 months in all subjects

  • Blood sample: Sub-study group

    Intervention · OTHER

    Monthly blood sample collection for 6 months

Study details

Official title
Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
Sponsor
Virginia Commonwealth University
Conditions
BK Virus Infection · Kidney Transplant; Complications
Enrolling
60 people
Starts
2024-05-29
Est. completion
2027-07
Record
View on ClinicalTrials.gov ↗