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

BK Virus (BKV) Viremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782209
• Other study ID #: DMID 11-0071
• Status: Completed
• Start date: June 2014
• Est. completion date: December 2019

Study information

• Verified date: July 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BK Virus (BKV) Viremia
• Viremia

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Colorado at Denver and HSC	Denver	Colorado
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University	New York	New York
United States	Washington University, Barnes Jewish Hospital	Saint Louis	Missouri
United States	California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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