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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01782209
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Richard J Whitley, University of Alabama at Birmingham

Tracking Information
First Submitted Date January 30, 2013
First Posted Date February 1, 2013
Results First Submitted Date July 9, 2020
Results First Posted Date July 28, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date June 2014
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2020)
Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: January 31, 2013)
To assess safety, both clinical and laboratory endpoints will be measured and analyzed for changes from baseline. [ Time Frame: Day 0 through day 42 for cohorts 1 and 3 or day 45 for cohorts 2 and 4 ]
Compare the number of adverse events from baseline to end of study between Placebo and CMX001 groups in each cohort.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients
Official Title Natural History of Infection Caused by BK Virus (and Other Opportunistic Viral Pathogens) in Renal Transplant Recipients
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood samples will be processed for serum and then evaluated for BK virus DNA
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
Condition BK Virus (BKV) Viremia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2020)
335
Original Estimated Enrollment
 (submitted: January 31, 2013)
24
Actual Study Completion Date December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01782209
Other Study ID Numbers DMID 11-0071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Richard J Whitley, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators Not Provided
Investigators
Principal Investigator: Richard J Whitley, MD University of Birmingham at Alabama
Study Chair: John W Gnann, MD Medical University of South Carolina
PRS Account University of Alabama at Birmingham
Verification Date July 2020