Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are * To determine the influence of CNI discontinuation on the drug exposure and key pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium (EC-MPS) * To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen * To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety (e.g. rejection rates) and tolerability * To investigate renal function after CsA withdrawal
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
oral
oral
Charité-Universitätsmedizin
Berlin, Germany
Kinetic Profiles (MPA, everolimus, and optional IMPDH) will be measured at day 0, 7 and 7 days after complete removal of CsA and last dose adjustment of everolimus due to trough level outside target range
Time frame: 7 days
Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12
Time frame: 1 year
Safety and tolerability of the treatment regimen consisting over a one year period
Time frame: 1 year
Renal function during the course of the trial, especially after CNI withdrawal.
Time frame: 1 year
Routine laboratory parameters during the course of the trial.
Time frame: 1 year
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