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Immune Registry for BK in Kidney Transplant Recipients

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

Who can join

Ages 18 and older · All sexes

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

About the study

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 is being tested

• Blood samples: Main Study group (other)
• Data Collection (other)
• Urine Sample- Main Study group (other)
• Urine sample- Sub-study group (other)
• Blood sample: Sub-study group (other)

Sponsor: Virginia Commonwealth University · Participants: 60 · Started: May 29, 2024

Contact the study team

• Ambreen Azhar · Phone: 804-828-4104
• Gelila Abebe · Phone: (804) 628-4969

Official record on ClinicalTrials.gov — NCT06538961

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.