BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | California Pacific Medical Center | San Francisco | California | United States | 94115 |
| 3 | University of Colorado at Denver and HSC | Denver | Colorado | United States | 80045 |
| 4 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 5 | Washington University, Barnes Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 6 | Columbia University | New York | New York | United States | 10032 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Richard J Whitley, MD, University of Birmingham at Alabama
- Study Chair: John W Gnann, MD, Medical University of South Carolina
Study Documents (Full-Text)
More Information
Publications
None provided.- DMID 11-0071
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Renal Transplant Patients |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Renal Transplant Patients |
|---|---|
| Arm/Group Description | Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection |
| Overall Participants | 335 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
49
(13.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
150
44.8%
|
| Male |
185
55.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
22
6.6%
|
| Not Hispanic or Latino |
313
93.4%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of 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 (participants) [Number] | |
| United States |
335
100%
|
Outcome Measures
| Title | Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Renal Transplant Patients |
|---|---|
| Arm/Group Description | Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection |
| Measure Participants | 335 |
| Count of Participants [Participants] |
58
17.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Renal Transplant Patients |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Incidence |
| Estimated Value | 17.3 | |
| Confidence Interval |
(2-Sided) 95% 13.4 to 21.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | 95% Clopper-Pearson Confidence Interval | |
Adverse Events
| Time Frame | 24 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Renal Transplant Patients | |
| 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 (%) | # Events | |
| Total | 4/335 (1.2%) | |
Serious Adverse Events |
||
| Renal Transplant Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/335 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Renal Transplant Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/335 (0.3%) | |
| Injury, poisoning and procedural complications | ||
| Bruising on left arm | 1/335 (0.3%) | 1 |
Limitations/Caveats
More Information
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
| Name/Title | Richard J. Whitley, MD |
|---|---|
| Organization | University of Alabama at Birmingham |
| Phone | 205.638.2530 |
| rwhitley@peds.uab.edu |
- DMID 11-0071