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

University Hospital Schleswig-Holstein15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

sirolimus, mycophenolat mofetil, fluvastatinDRUG

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: 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)

Data from ClinicalTrials.gov

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