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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Schleswig-Holstein; University of Schleswig-Holstein
• Treatments: Everolimus; Fluvastatin; Sirolimus

Criteria

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)