Skip to main content
OpenTrials
Completed

NCT Number: NCT01094691

Haufen Diagnostic Biomarkers of BK Renal Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polyoma Virus Nephropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina-CH Dept of Pathology

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Allograft Biopsy

Procedure

A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2010
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.