Polyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exists. Modifying the infection is usually tried by lowering immunosuppression, which may lead to transplant failure by rejection as well. A randomized switch of immunosuppression to everolimus vs general lowering of immunosuppression has to be tested (prospect. random. parallel group comparison).
Conditions
Interventions
Trade Name: Certican 0.25mg
Product Name: Everolimus 0.25 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351-69-6
Current Sponsor code: mTOR-inhibitor
Other descriptive
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Preceding transplantation; functioning graft with a permanent glomerular filtration rate of >30mL/min; bioptically confirmed polyomavirus BK nephropathy; age of 19 - 75 years; written consent of the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy; known intolerance of the planned medication (e.g. severe diarrhea, angioedema, severe wound healing problem, uncontrolled infectious diseases other than BK virus); leucopenia <2000/µL; permanent glomerular filtration rate of <30mL/min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to find out if switch to mTOR inhibitor everolimus will be superior compared to lowering of conventional immunosuppression by calcineurin inhibitor in eliminating polyoma BK virus and thus saving the transplant. Therefore graft survival in the 2 groups will be compared (primary efficacy endpoint: time to death or time to graft loss or permanent decrease of glomerular filtration rate to one log; decrease of serum creatinine of >25%; progression of tubular atrophy and interstitial fibrosis in follow-up histology in %; number of rejections under changement of immunosuppression; increase of BKV-specific T-cells).;Primary end point(s): Time to death or time to graft loss or permanent glomerular filtration rate to <25mL/min which ever occurs first. | — |
Countries
Germany
Outcome results
None listed