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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Allograft Biopsy | Experimental | Urine left over from clinic visits is analyzed for 'Haufen' by negative staining electron microscopy as a marker of intra-renal polyomavirus nephropathy. Correlate Haufen, urine, and plasma data with the clinical presentation and with renal biopsy findings. Patients with PVN will be approached for study participation in which their routine samples will be monitored until urine is negative for 'Haufen', and a study protocol biopsy will be obtained for confirmation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Allograft Biopsy | Procedure | A renal allograft biopsy will be performed when the urine is determined to be Haufen negative. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings. | The biopsy will be performed when urine is determined to be Haufen negative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Nickeleit, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina-CH Dept of Pathology | Chapel Hill | North Carolina | 27599 | United States |
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