RecruitingNCT06538961

Immune Registry for BK in Kidney Transplant Recipients

Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients


Sponsor

Virginia Commonwealth University

Enrollment

60 participants

Start Date

May 29, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria2

  • Prisoners will not be included in the study
  • Multi-organ transplants and pregnant women

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Interventions

OTHERBlood samples: Main Study group

the collection of blood samples at specified time points.

OTHERData Collection

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

OTHERUrine Sample- Main Study group

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

OTHERUrine sample- Sub-study group

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

OTHERBlood sample: Sub-study group

Monthly blood sample collection for 6 months


Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT06538961


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