Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition BK Virus (BKV) Viremia
Enrollment 335
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Renal Transplant Patients
Hide Arm/Group Description Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Period Title: Overall Study
Started 335
Completed 225
Not Completed 110
Arm/Group Title Renal Transplant Patients
Hide Arm/Group Description Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Overall Number of Baseline Participants 335
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 335 participants
49  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants
Female 150
Male 185
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants
Hispanic or Latino
22
   6.6%
Not Hispanic or Latino
313
  93.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 335 participants
American Indian or Alaska Native
2
   0.6%
Asian
11
   3.3%
Native Hawaiian or Other Pacific Islander
3
   0.9%
Black or African American
100
  29.9%
White
214
  63.9%
More than one race
3
   0.9%
Unknown or Not Reported
2
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 335 participants
335
1.Primary Outcome
Title Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects
Hide Description We will measure the number of subjects screened who develops BK viremia within 4 weeks and up to 24 months after renal transplant
Time Frame within 4 weeks and up to 24 months after renal transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Renal Transplant Patients
Hide Arm/Group Description:
Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Overall Number of Participants Analyzed 335
Measure Type: Count of Participants
Unit of Measure: Participants
58
  17.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Renal Transplant Patients
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence
Estimated Value 17.3
Confidence Interval (2-Sided) 95%
13.4 to 21.8
Estimation Comments 95% Clopper-Pearson Confidence Interval
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Renal Transplant Patients
Hide Arm/Group Description Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
All-Cause Mortality
Renal Transplant Patients
Affected / at Risk (%)
Total   4/335 (1.19%)    
Hide Serious Adverse Events
Renal Transplant Patients
Affected / at Risk (%) # Events
Total   0/335 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Renal Transplant Patients
Affected / at Risk (%) # Events
Total   1/335 (0.30%)    
Injury, poisoning and procedural complications   
Bruising on left arm *  1/335 (0.30%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard J. Whitley, MD
Organization: University of Alabama at Birmingham
Phone: 205.638.2530
EMail: rwhitley@peds.uab.edu
Layout table for additonal information
Responsible Party: Richard J Whitley, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01782209    
Other Study ID Numbers: DMID 11-0071
First Submitted: January 30, 2013
First Posted: February 1, 2013
Results First Submitted: July 9, 2020
Results First Posted: July 28, 2020
Last Update Posted: July 28, 2020