Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
NCT ID: NCT01289301
Last Updated: 2011-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
124 participants
INTERVENTIONAL
2011-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mTOR-receiving arm
switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression
mTOR inhibitor (everolimus)
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
calcineurin-inhibitor keeping arm
continuing calcineurin-inhibitor based immunosuppression
cyclosporine or tacrolimus
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
Interventions
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mTOR inhibitor (everolimus)
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
cyclosporine or tacrolimus
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* pregnancy
18 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Medizinische Hochschule
Principal Investigators
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Anke Schwarz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School, Nephrology
Hermann Haller, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School, Nephrology
Silvia Linnenweber, Dr.
Role: STUDY_CHAIR
Hannover Medical School, Nephrology
Armin Koch, Prof. Dr.
Role: STUDY_DIRECTOR
Hannover Medical School, Biometry
Albert Heim, PD Dr.
Role: STUDY_DIRECTOR
Hannover Medical School, Virology
Verena Broecker, Dr.
Role: STUDY_CHAIR
Hannover Medical School, Pathology
Locations
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University Hospital Freiburg, Transplant Outpatient Clinic
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
Erlangen, Bavaria, Germany
Hannover Medical School, Transplant Outpatient Clinic
Hanover, Lower Saxony, Germany
University of Essen, Transplant Outpatient Clinic
Essen, Ruhrgebiet, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Polyoma IFB 29
Identifier Type: -
Identifier Source: org_study_id
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