Official Title: “Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation”

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

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: sirolimus, mycophenolat mofetil, fluvastatin

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Schleswig-Holstein

Overall Clinical Trial Officials and Contacts

Lutz Renders, MD Principal Investigator University of Schleswig-Holstein, Campus Kiel, Department of Nephrology  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00223028

Study ID Number: 003

ClinicalTrials.gov Identifier: NCT00223028

Health Authority: Germany: Federal Institute for Drugs and Medical Devices