Renal Transplantation
Conditions
Keywords
Kidney Transplantation, Renal Transplantation, Mycophenolate, Cyclosporine, Everolimus
Brief summary
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
Interventions
DRUGeverolimus
oral
Sponsors
Novartis
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients having a kidney transplant since at least 6 months but for no longer than 5 years. * Patients in a stable condition in terms of graft function * Patients currently receiving EC-MPS and CsA with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month prior to Baseline * Females of childbearing potential must have a negative serum pregnancy test prior to study inclusion. If positive, the patient will not be enrolled. Effective contraception must be used during the trial.
Exclusion criteria
* Patients with any known hypersensitivity to EC-MPS or everolimus or other components of the formulation (e.g., lactose) * Patients with a history of severe rejection (according to BANFF criteria) within 3 months of enrollment in this trial. * Changes to the immunosuppressive regimen during the last 3 months due to immunologic reasons. * Patients with thrombocytopenia (platelets \<100,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (leukocytes \<4,500/mm3), and/or hemoglobin \<9.0 g/dL at baseline. * Patients with proteinuria at baseline (\> 1g/d) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 7 days |
| Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the treatment regimen consisting over a one year period | 1 year |
| Renal function during the course of the trial, especially after CNI withdrawal. | 1 year |
| Routine laboratory parameters during the course of the trial. | 1 year |
Countries
Germany
Outcome results
None listed