BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01782209
Recruitment Status :
First Posted : February 1, 2013
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
University of Alabama at Birmingham
Information provided by (Responsible Party):
Richard J Whitley, University of Alabama at Birmingham
The objectives of this study is to establish the natural history of BK virus viremia and other possible opportunistic viral pathogens in renal transplants recipients.
Condition or disease
BK Virus (BKV) Viremia
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female renal or renal-pancreas transplant recipients ages 18 and older at risk for BKV infection
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.
Evidence of proven or suspected BKVN by clinical or pathologic diagnostic criteria Loss of renal graft function Initiation of chronic dialysis