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

University of Alabama at Birmingham335 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

335

Conditions

BK Virus (BKV) Viremia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

University of Alabama at Birmingham

Birmingham, Alabama, United States

California Pacific Medical Center

San Francisco, California, United States

University of Colorado at Denver and HSC

Denver, Colorado, United States

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects

We will measure the number of subjects screened who develops BK viremia within 4 weeks and up to 24 months after renal transplant

Time frame: within 4 weeks and up to 24 months after renal transplant

Data from ClinicalTrials.gov

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