NCT01094691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

10.7 years

First QC Date

March 25, 2010

Last Update Submit

June 8, 2023

Conditions

Polyoma Virus Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings.

    The biopsy will be performed when urine is determined to be Haufen negative

Study Arms (1)

Renal Allograft Biopsy

EXPERIMENTAL

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

Interventions

Renal Allograft BiopsyPROCEDURE

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

Renal Allograft Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Recipient of renal transplant
  • Positive for polyoma virus
  • Haufen cells present in urine
  • Positive for polyoma virus nephropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina-CH Dept of Pathology

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

  • Volker Nickeleit, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

November 1, 2008

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

US(1)