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

Completed

• Conditions: BK Virus (BKV) Viremia

• Registration Number: NCT01782209
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Study Start: 2014-06
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-07
• Results First Submitted: 2020-07-09
• Results First Submitted QC: 2020-07-09
• Last Update Submitted: 2020-07-09
• Results First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects	within 4 weeks and up to 24 months after renal transplant	We will measure the number of subjects screened who develops BK viremia within 4 weeks and up to 24 months after renal transplant

Trial Locations

Locations (6)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Washington University, Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

University of Colorado at Denver and HSC; 🇺🇸 Denver, Colorado, United States