Status:
COMPLETED
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat 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
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 therap...
Eligibility Criteria
Inclusion
- 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
- 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 :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00223028
Start Date
April 1 2005
End Date
July 1 2005
Last Update
October 28 2005
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