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

Phase 4

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00223028
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2004-07
• Study Start: 2005-04
• Study Completion: 2005-07
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Last Update Submitted: 2005-10-27
• Last Update Posted: 2005-10-28

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: 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP