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Haufen Diagnostic Biomarkers of BK Renal Disease

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01094691
First Posted: March 29, 2010
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Volker Nickeleit, MD, University of North Carolina, Chapel Hill
  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: None (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 Volker Nickeleit, MD, 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 ]

Estimated Enrollment: 10
Study Start Date: November 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 25, 2010
First Posted: March 29, 2010
Last Update Posted: April 19, 2017
Last Verified: April 2017


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