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Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant (BKVIRUS)

Primary Purpose

Disorder Related to Renal Transplantation, Immunosuppression Related Infectious Disease, Virus Diseases

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
mTOR inhibitor (everolimus)
cyclosporine or tacrolimus
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder Related to Renal Transplantation focused on measuring renal transplantation, polyoma BK virus infection, everolimus, calcineurin inhibitor, mTOR inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preceding renal transplantation
  • functioning graft with a permanent creatinine clearance of more than 25mL/min
  • biopsy-confirmed polyoma BK virus nephropathy
  • age over 18 years old

Exclusion Criteria:

  • allergy or non-tolerance of the study medication everolimus
  • pregnancy

Sites / Locations

  • University Hospital Freiburg, Transplant Outpatient Clinic
  • University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
  • Hannover Medical School, Transplant Outpatient Clinic
  • University of Essen, Transplant Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mTOR-receiving arm

calcineurin-inhibitor keeping arm

Arm Description

switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression

continuing calcineurin-inhibitor based immunosuppression

Outcomes

Primary Outcome Measures

death or graft loss
after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function

Secondary Outcome Measures

decrease of polyomavirus serum PCR
regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)
decrease of creatinine
regular measurment of graft function (every 4 weeks to 3 months)
progression of chronic changes in renal histology
renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy
number of rejections following intervention
biopsy-verified rejections (graft biopsies on indication) may be a consequence of changement of immunosuppression and a side effect of it, rejections will be counted
increase of BKV-specific T-cells
increase of BKV-specific T-cells are a sign of overcoming viral infection and will be counted regularly (every 3 to 6 months)

Full Information

First Posted
February 2, 2011
Last Updated
February 2, 2011
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01289301
Brief Title
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
Acronym
BKVIRUS
Official Title
Polyomavirus BK Nephropathy After Renal Transplantation: Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.
Detailed Description
The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder Related to Renal Transplantation, Immunosuppression Related Infectious Disease, Virus Diseases
Keywords
renal transplantation, polyoma BK virus infection, everolimus, calcineurin inhibitor, mTOR inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mTOR-receiving arm
Arm Type
Experimental
Arm Description
switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression
Arm Title
calcineurin-inhibitor keeping arm
Arm Type
Active Comparator
Arm Description
continuing calcineurin-inhibitor based immunosuppression
Intervention Type
Drug
Intervention Name(s)
mTOR inhibitor (everolimus)
Other Intervention Name(s)
switch immunosuppression to everolimus
Intervention Description
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
Intervention Type
Drug
Intervention Name(s)
cyclosporine or tacrolimus
Other Intervention Name(s)
keeping immunosuppression with calcineurin inhibitor, cyclosporine, tacrolimus
Intervention Description
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
Primary Outcome Measure Information:
Title
death or graft loss
Description
after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function
Time Frame
2 years of observation
Secondary Outcome Measure Information:
Title
decrease of polyomavirus serum PCR
Description
regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)
Time Frame
2 years
Title
decrease of creatinine
Description
regular measurment of graft function (every 4 weeks to 3 months)
Time Frame
2 years observation
Title
progression of chronic changes in renal histology
Description
renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy
Time Frame
renal biopsy 3 months after intervention
Title
number of rejections following intervention
Description
biopsy-verified rejections (graft biopsies on indication) may be a consequence of changement of immunosuppression and a side effect of it, rejections will be counted
Time Frame
2 years after intervention
Title
increase of BKV-specific T-cells
Description
increase of BKV-specific T-cells are a sign of overcoming viral infection and will be counted regularly (every 3 to 6 months)
Time Frame
2 years observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preceding renal transplantation functioning graft with a permanent creatinine clearance of more than 25mL/min biopsy-confirmed polyoma BK virus nephropathy age over 18 years old Exclusion Criteria: allergy or non-tolerance of the study medication everolimus pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anke Schwarz, Prof. Dr.
Phone
+49 511 532 2329
Email
schwarz.anke@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hermann Haller, Prof. Dr.
Phone
+49 511 5326319
Email
haller.hermann@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Schwarz, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Nephrology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hermann Haller, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Nephrology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Linnenweber, Dr.
Organizational Affiliation
Hannover Medical School, Nephrology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Armin Koch, Prof. Dr.
Organizational Affiliation
Hannover Medical School, Biometry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Albert Heim, PD Dr.
Organizational Affiliation
Hannover Medical School, Virology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Verena Broecker, Dr.
Organizational Affiliation
Hannover Medical School, Pathology
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Freiburg, Transplant Outpatient Clinic
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
D-79104
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerd Walz, Prof. Dr.
Phone
0761 2703250
Email
gerd.walz@uniklinik-freiburg.de
Facility Name
University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
D-91054
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Hilgers, Prof. Dr.
Phone
+49 9131 8536267
Email
karl.hilgers@uk-erlangen.de
Facility Name
Hannover Medical School, Transplant Outpatient Clinic
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
D-30625
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke Schwarz, Prof. Dr.
Phone
+49 511 5322329
Email
schwarz.anke@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Silvia Linnenweber, Dr.
Phone
+49 511 5323000
Email
linnenweber.silvia@mh-hannover.de
Facility Name
University of Essen, Transplant Outpatient Clinic
City
Essen
State/Province
Ruhrgebiet
ZIP/Postal Code
D-45122
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Witzke, Prof. Dr.
Phone
+49 201 7231868
Email
nephrologie@uk-essen.de

12. IPD Sharing Statement

Learn more about this trial

Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant

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