BK Virus (BKV) Viremia
Conditions
Keywords
BK virus viremia, renal transplant, other viral pathogens
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.
Interventions
None listed
Sponsors
University of Alabama at Birmingham
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renal Transplant Patients Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection | 335 |
| Total | 335 |
Baseline characteristics
| Characteristic | Renal Transplant Patients |
|---|---|
| Age, Continuous | 49 Years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 313 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 100 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 214 Participants |
| Region of Enrollment United States | 335 participants |
| Sex: Female, Male Female | 150 Participants |
| Sex: Female, Male Male | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 335 |
| other Total, other adverse events | 1 / 335 |
| serious Total, serious adverse events | 0 / 335 |
Outcome results
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
Time frame: within 4 weeks and up to 24 months after renal transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Transplant Patients | Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects | 58 Participants |
95% CI: [13.4, 21.8]