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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289301
Recruitment Status : Unknown
Verified October 2010 by Hannover Medical School.
Recruitment status was:  Not yet recruiting
First Posted : February 3, 2011
Last Update Posted : February 3, 2011
Information provided by:
Hannover Medical School

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.

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Immunosuppression Related Infectious Disease Virus Diseases Drug: mTOR inhibitor (everolimus) Drug: cyclosporine or tacrolimus Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2011
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: mTOR-receiving arm
switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression
Drug: mTOR inhibitor (everolimus)
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
Other Name: switch immunosuppression to everolimus

Active Comparator: calcineurin-inhibitor keeping arm
continuing calcineurin-inhibitor based immunosuppression
Drug: cyclosporine or tacrolimus
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
Other Names:
  • keeping immunosuppression with calcineurin inhibitor
  • cyclosporine
  • tacrolimus

Primary Outcome Measures :
  1. death or graft loss [ Time Frame: 2 years of observation ]
    after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function

Secondary Outcome Measures :
  1. decrease of polyomavirus serum PCR [ Time Frame: 2 years ]
    regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)

  2. decrease of creatinine [ Time Frame: 2 years observation ]
    regular measurment of graft function (every 4 weeks to 3 months)

  3. progression of chronic changes in renal histology [ Time Frame: renal biopsy 3 months after intervention ]
    renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy

  4. number of rejections following intervention [ Time Frame: 2 years after 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

  5. increase of BKV-specific T-cells [ Time Frame: 2 years observation ]
    increase of BKV-specific T-cells are a sign of overcoming viral infection and will be counted regularly (every 3 to 6 months)

Information from the National Library of Medicine

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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:

  • 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

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 identifier (NCT number): NCT01289301

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Contact: Anke Schwarz, Prof. Dr. +49 511 532 2329
Contact: Hermann Haller, Prof. Dr. +49 511 5326319

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University Hospital Freiburg, Transplant Outpatient Clinic
Freiburg, Baden-Württemberg, Germany, D-79104
Contact: Gerd Walz, Prof. Dr.    0761 2703250   
University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
Erlangen, Bayern, Germany, D-91054
Contact: Karl Hilgers, Prof. Dr.    +49 9131 8536267   
Hannover Medical School, Transplant Outpatient Clinic
Hannover, Niedersachsen, Germany, D-30625
Contact: Anke Schwarz, Prof. Dr.    +49 511 5322329   
Contact: Silvia Linnenweber, Dr.    +49 511 5323000   
University of Essen, Transplant Outpatient Clinic
Essen, Ruhrgebiet, Germany, D-45122
Contact: Oliver Witzke, Prof. Dr.    +49 201 7231868   
Sponsors and Collaborators
Hannover Medical School
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Principal Investigator: Anke Schwarz, Prof. Dr. Hannover Medical School, Nephrology
Principal Investigator: Hermann Haller, Prof. Dr. Hannover Medical School, Nephrology
Study Chair: Silvia Linnenweber, Dr. Hannover Medical School, Nephrology
Study Director: Armin Koch, Prof. Dr. Hannover Medical School, Biometry
Study Director: Albert Heim, PD Dr. Hannover Medical School, Virology
Study Chair: Verena Broecker, Dr. Hannover Medical School, Pathology
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Responsible Party: Clinical Research Center, Medizinische Hochschule Identifier: NCT01289301    
Other Study ID Numbers: Polyoma IFB 29
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: October 2010
Keywords provided by Hannover Medical School:
renal transplantation
polyoma BK virus infection
calcineurin inhibitor
mTOR inhibitor
Additional relevant MeSH terms:
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Communicable Diseases
Virus Diseases
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic