Haufen Diagnostic Biomarkers of BK Renal Disease

University of North Carolina (UNC)

Status: Completed

Conditions: Polyoma Virus Nephropathy

Treatments: Procedure: Renal Allograft Biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01094691

08-1519

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• anyone who does not meet the inclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Renal Allograft Biopsy

Experimental group

Description:

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:

Procedure: Renal Allograft Biopsy