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

University Hospital Schleswig-Holstein15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

Fluvastatin, Tacrolimus, Mycophenolat MofetilDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Data from ClinicalTrials.gov

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