Clinical trial NCT01782209: BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients
Official title: Natural History of Infection Caused by BK Virus (and Other Opportunistic Viral Pathogens) in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BK Virus (BKV) Viremia
Keywords: BK virus viremia
renal transplant
other viral pathogens
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female renal or renal-pancreas transplant recipients ages 18 and older at risk for BKV infection

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects
timeFrame: within 4 weeks and up to 24 months after renal transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado at Denver and HSC
state: Colorado
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University, Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: University of Birmingham at Alabama
name: Richard J Whitley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: John W Gnann, MD
role: STUDY_CHAIR
References: