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

Phase 4

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00223015
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2004-05
• Study Start: 2004-05
• Study Completion: 2005-04
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Last Update Submitted: 2005-10-19
• Last Update Posted: 2005-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP