Haufen Diagnostic Biomarkers of BK Renal Disease



Status:Enrolling by invitation
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:November 2008
End Date:December 2019

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Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study

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.


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
We found this trial at
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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