Haufen Diagnostic Biomarkers of BK Renal Disease

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Volker Nickeleit, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01094691
First received: March 25, 2010
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Polyoma Virus Nephropathy
Procedure: Renal Allograft Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Allograft Biopsy Procedure: Renal Allograft Biopsy
A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094691

Locations
United States, North Carolina
University of North Carolina-CH Dept of Pathology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Volker Nickeleit, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Volker Nickeleit, MD, Director of the UNC Division of Nephropathology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01094691     History of Changes
Other Study ID Numbers: 08-1519
Study First Received: March 25, 2010
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014