BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients

This is a Natural History study in renal or renal-pancreas transplant recipients. In an
effort to capture patients early in the course of an evolving BK virus infection and avoid
patients who have already developed evidence of BKV-induced nephropathy (BKVN), this protocol
will emphasize the initiation of screening in the early post-transplant period. Patients who
have undergone renal or renal/pancreas transplantation within 4 weeks, but not more than 90
day previously, will be asked to participate and then consented to be enrolled in a Natural
History-Surveillance period for up to approximately 24 months. Participants enrolled in this
study will provide valuable natural history data regarding BKV viremia, and potentially other
viral pathogen, in the post-renal transplant period. Participants will provide blood samples
to undergo measurement for plasma BKV DNA by PCR approximately every 6 weeks, to be resulted
in real time at the UAB Diagnostic Virology Laboratory at UAB.

Inclusion Criteria:

Renal or renal-pancreas transplant patients who are within 4 weeks and not more than 90
days post-transplant with or without qualifying BKV viremia Age greater than or equal to 18
years; Provides written informed consent.

Exclusion Criteria:

Evidence of proven or suspected BKVN by clinical or pathologic diagnostic criteria Loss of
renal graft function Initiation of chronic dialysis