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...
Date First Received: September 14, 2005
Last Updated: October 19, 2005
Verified by: University of Schleswig-Holstein, May 2004
Clinical Trial Phase: Phase 4 | Start Date: May 2004
Overall Status: Completed
Estimated Enrollment: 15
Brief Summary
Condition Keyword(s):
Intervention(s):
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
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil
Criteria for Participation in this Clinical Trial
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)
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
Clinical Trial Sponsor Information
Lead Sponsor: University of Schleswig-Holstein
Overall Clinical Trial Officials and Contacts
Lutz Renders, MD Principal Investigator University of Schleswig-Holstein, campus Kiel Department odf Nephrology
Additional Information
Information obtained from ClinicalTrials.gov on October 15, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00223015
Study ID Number: 002
ClinicalTrials.gov Identifier: NCT00223015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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