drugset / Trial / NCT00443937
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2004-01
- Primary completion
- —
- Completion
- 2006-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | — | Oral |
| Subject | mycophenolic acid | Small molecule | — | Oral |
Indications
No indication recorded.