Haufen Diagnostic Biomarkers of BK Renal Disease

Not Applicable

Completed

• Conditions: Polyoma Virus Nephropathy
• Interventions: Procedure: Renal Allograft Biopsy

• Registration Number: NCT01094691
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-29
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 18 or older
• Recipient of renal transplant
• Positive for polyoma virus
• Haufen cells present in urine
• Positive for polyoma virus nephropathy

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Exclusion Criteria

• anyone who does not meet the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Allograft Biopsy	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of North Carolina-CH Dept of Pathology; 🇺🇸 Chapel Hill, North Carolina, United States