Polyoma Virus Nephropathy
Conditions
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.
Interventions
PROCEDURERenal Allograft Biopsy
A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.
Sponsors
Astellas Pharma US, Inc.
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed