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Trial record 1 of 1 for:    nct01094691
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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

March 25, 2010
April 9, 2014
November 2008
December 2015   (final data collection date for primary outcome measure)
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 ]
Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01094691 on ClinicalTrials.gov Archive Site
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Haufen Diagnostic Biomarkers of BK Renal Disease
Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study

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.

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Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Polyoma Virus Nephropathy
Procedure: Renal Allograft Biopsy
A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.
Experimental: Renal Allograft Biopsy
Intervention: Procedure: Renal Allograft Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01094691
08-1519
No
Volker Nickeleit, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Astellas Pharma US, Inc.
Principal Investigator: Volker Nickeleit, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP