BK Virus (BKV) ViremiaNCT01782209
BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients
An observational study of BK Virus (BKV) Viremia, run by University of Alabama at Birmingham at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Virus (BKV) Viremia
- How many people
- 335 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2014to Dec 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female renal or renal-pancreas transplant recipients ages 18 and older at risk for BKV infection
Who may be able to join
- 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.
Who cannot join
- Evidence of proven or suspected BKVN by clinical or pathologic diagnostic criteria Loss of renal graft function Initiation of chronic dialysis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Colorado at Denver and HSC
Denver, Colorado, 80045
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University
New York, New York, 10032
California Pacific Medical Center
San Francisco, California, 94115
Washington University, Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- BK Virus (BKV) Viremia
- Keywords
- BK virus viremia, renal transplant, other viral pathogens
- Medical subject headings
- Viremia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 4 weeks and up to 24 months after renal transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJun 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BK Virus (BKV) ViremiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J Whitley, University of Alabama at Birmingham
- Investigators
- Richard J Whitley, MD, Principal investigator, University of Birmingham at AlabamaJohn W Gnann, MD, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782209
- Sponsor's protocol ID
- DMID 11-0071
- Status last verified
- Jul 2020
- First submitted
- 30 Jan 2013
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided