Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included

Inclusion Criteria:

• renal transplant patients (18 - 65 years, inclusive)
• cadaver and living renal transplants(1. Ntx, 2. Ntx)
• Immunsuppression: sirolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months
• writen informt consent by the patient

Exclusion Criteria:

• contraindications for statins
• pregnancy or lactating
• elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)