Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
Phase 4
Completed
- Conditions
- Renal Transplantation
- Registration Number
- NCT00443937
- Lead Sponsor
- Charite University, Berlin, Germany
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Charité-Universitätsmedizin
🇩🇪Berlin, Germany