Status:
COMPLETED
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation
Lead Sponsor:
University Hospital Schleswig-Holstein
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 enro...
Eligibility Criteria
Inclusion
- 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
- contraindications for statins
- pregnancy or lactating
- elevated liver or muscle encymes (\> 2x up to normal values: AST, ALT, bilirubine, CPK)
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00223015
Start Date
May 1 2004
End Date
April 1 2005
Last Update
October 20 2005
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