Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
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.
Description
As with other viral infections, adaptive immunity plays an essential role in the control of BK virus infection. Previous studies have shown that humoral immunity doesn't prevent viral reactivation and cellular responses including CD4+ and CD8+ T cells play a crucial role in containing viral replication. Researchers have investigated the role of reconstitution of BK-specific T cell immunity KT recipients with overall low immunological risk populations showing that pre and post-transplant BK virus-specific cellular responses can be used as an important tool to identify KT recipients at increased…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). Exclusion Criteria: * Prisoners will not be included in the study * Multi-organ transplants and pregnant women
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
Location
- Virginia Commonwealth UniversityRichmond, Virginia