Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
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...
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
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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 Investigator Information
Lead Investigator: University of Schleswig-Holstein Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00223015
