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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.
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

February 2, 2011
February 2, 2011
October 2011
October 2017   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Disorder Related to Renal Transplantation
  • Immunosuppression Related Infectious Disease
  • Virus Diseases
  • 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
  • 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
  • Experimental: mTOR-receiving arm
    switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression
    Intervention: Drug: mTOR inhibitor (everolimus)
  • Active Comparator: calcineurin-inhibitor keeping arm
    continuing calcineurin-inhibitor based immunosuppression
    Intervention: Drug: cyclosporine or tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
124
October 2018
October 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Germany
 
NCT01289301
Polyoma IFB 29
Yes
Clinical Research Center, Medizinische Hochschule
Hannover Medical School
Not Provided
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
Hannover Medical School
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP