Clinical Trial: Haufen Diagnostic Biomarkers of BK Renal Disease

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings. [ Time Frame: The biopsy will be performed when urine is determined to be Haufen negative ]

Original Primary Outcome: Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: March 25, 2010
Date Started: November 2008
Date Completion: December 2019
Last Updated: April 17, 2017
Last Verified: April 2017