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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2010 by Hannover Medical School
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01289301
First received: February 2, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • death or graft loss [ Time Frame: 2 years of observation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)

  • decrease of creatinine [ Time Frame: 2 years observation ] [ Designated as safety issue: No ]
    regular measurment of graft function (every 4 weeks to 3 months)

  • progression of chronic changes in renal histology [ Time Frame: renal biopsy 3 months after intervention ] [ Designated as safety issue: No ]
    renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy

  • number of rejections following intervention [ Time Frame: 2 years after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years observation ] [ Designated as safety issue: No ]
    increase of BKV-specific T-cells are a sign of overcoming viral infection and will be counted regularly (every 3 to 6 months)


Estimated Enrollment: 124
Study Start Date: October 2011
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289301

Contacts
Contact: Anke Schwarz, Prof. Dr. +49 511 532 2329 schwarz.anke@mh-hannover.de
Contact: Hermann Haller, Prof. Dr. +49 511 5326319 haller.hermann@mh-hannover.de

Locations
Germany
University Hospital Freiburg, Transplant Outpatient Clinic Not yet recruiting
Freiburg, Baden-Württemberg, Germany, D-79104
Contact: Gerd Walz, Prof. Dr.    0761 2703250    gerd.walz@uniklinik-freiburg.de   
University of Erlangen/ Nürnberg, Transplant Outpatient Clinic Not yet recruiting
Erlangen, Bayern, Germany, D-91054
Contact: Karl Hilgers, Prof. Dr.    +49 9131 8536267    karl.hilgers@uk-erlangen.de   
Hannover Medical School, Transplant Outpatient Clinic Not yet recruiting
Hannover, Niedersachsen, Germany, D-30625
Contact: Anke Schwarz, Prof. Dr.    +49 511 5322329    schwarz.anke@mh-hannover.de   
Contact: Silvia Linnenweber, Dr.    +49 511 5323000    linnenweber.silvia@mh-hannover.de   
University of Essen, Transplant Outpatient Clinic Not yet recruiting
Essen, Ruhrgebiet, Germany, D-45122
Contact: Oliver Witzke, Prof. Dr.    +49 201 7231868    nephrologie@uk-essen.de   
Sponsors and Collaborators
Hannover Medical School
Investigators
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
  More Information

No publications provided

Responsible Party: Clinical Research Center, Medizinische Hochschule
ClinicalTrials.gov Identifier: NCT01289301     History of Changes
Other Study ID Numbers: Polyoma IFB 29
Study First Received: February 2, 2011
Last Updated: February 2, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
renal transplantation
polyoma BK virus infection
everolimus
calcineurin inhibitor
mTOR inhibitor

Additional relevant MeSH terms:
Communicable Diseases
Infection
Virus Diseases
Cyclosporins
Cyclosporine
Everolimus
Sirolimus
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014