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Trial record 1 of 1 for:    nct01094691
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Haufen Diagnostic Biomarkers of BK Renal Disease

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ClinicalTrials.gov Identifier: NCT01094691
Recruitment Status : Suspended (Temporary suspension of recruitment and research activities due to COVID-19)
First Posted : March 29, 2010
Last Update Posted : April 15, 2022
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Polyoma Virus Nephropathy Procedure: Renal Allograft Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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
Study Start Date : November 2008
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Arm Intervention/treatment
Experimental: Renal Allograft Biopsy
Urine left over from clinic visits is analyzed for 'Haufen' by negative staining electron microscopy as a marker of intra-renal polyomavirus nephropathy. Correlate Haufen, urine, and plasma data with the clinical presentation and with renal biopsy findings. Patients with PVN will be approached for study participation in which their routine samples will be monitored until urine is negative for 'Haufen', and a study protocol biopsy will be obtained for confirmation.
Procedure: Renal Allograft Biopsy
A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.

Primary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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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.
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Principal Investigator: Volker Nickeleit, MD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01094691    
Other Study ID Numbers: 08-1519
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022