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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: sirolimus, mycophenolat mofetil, fluvastatin
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: 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
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 of Nephrology
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00223028
