Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2008-11-30
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Renal Allograft Biopsy
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.
Renal Allograft Biopsy
A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.
Interventions
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Renal Allograft Biopsy
A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.
Eligibility Criteria
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Inclusion Criteria
* Recipient of renal transplant
* Positive for polyoma virus
* Haufen cells present in urine
* Positive for polyoma virus nephropathy
18 Years
ALL
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Volker Nickeleit, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina-CH Dept of Pathology
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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08-1519
Identifier Type: -
Identifier Source: org_study_id
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