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Renal Allograft Biopsy for Polyomavirus Nephropathy

N/A
Waitlist Available
Led By Volker Nickeleit, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal Allograft BiopsyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Allograft Biopsy
2008
N/A
~50

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,248,992 Total Patients Enrolled
Astellas Pharma US, Inc.Industry Sponsor
88 Previous Clinical Trials
12,787 Total Patients Enrolled
Volker Nickeleit, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
~3 spots leftby Sep 2025
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