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

Natural History of Infection Caused by BK Virus (and Other Opportunistic Viral Pathogens) in Renal Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: BK Virus (BKV) Viremia

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.

• Study Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado at Denver and HSC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University, Barnes Jewish Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 4 weeks and up to 24 months after renal transplant

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Richard J Whitley, MD, University of Birmingham at Alabama; Study Chair: John W Gnann, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: January 30, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: renal transplant; BK virus viremia; other viral pathogens
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Viremia
• Other Study ID Numbers: DMID 11-0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided