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

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: sirolimus, mycophenolat mofetil, fluvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00223028

003

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)