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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
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
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
Time frame: 2 years of observation
decrease of polyomavirus serum PCR
regular measurement of polyomavirus serum PCR (every 4 weeks to 3 months)
Time frame: 2 years
decrease of creatinine
regular measurment of graft function (every 4 weeks to 3 months)
Time frame: 2 years observation
progression of chronic changes in renal histology
renal rebiopsy and comparison of chronic changes in renal biopsy with the diagnostic renal biopsy
Time frame: renal biopsy 3 months after intervention
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
Time frame: 2 years after intervention
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)
Time frame: 2 years observation
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