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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 4 weeks and up to 24 months after renal transplant |
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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
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Male and female renal or renal-pancreas transplant recipients ages 18 and older at risk for BKV infection
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| Name | Affiliation | Role |
|---|---|---|
| Richard J Whitley, MD | University of Birmingham at Alabama | Principal Investigator |
| John W Gnann, MD | Medical University of South Carolina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| California Pacific Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Transplant Patients | Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Transplant Patients | Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | within 4 weeks and up to 24 months after renal transplant |
|
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Renal Transplant Patients | Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising on left arm | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard J. Whitley, MD | University of Alabama at Birmingham | 205.638.2530 | rwhitley@peds.uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2016 | Jul 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014766 | Viremia |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
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Whole blood samples will be processed for serum and then evaluated for BK virus DNA
| San Francisco |
| California |
| 94115 |
| United States |
| University of Colorado at Denver and HSC | Denver | Colorado | 80045 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University, Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 4 |
| 335 |
| 0 |
| 335 |
| 1 |
| 335 |
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| D007249 |
| Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |