Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT00223015

002

Details and patient eligibility

About

Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs.

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 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: Tacrolimus 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: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)