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NCT00223028 Clinical Trial

Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Renal Transplantation Clinical Trial

Official title:
Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00223028
Other study ID # 003
Secondary ID
Status Completed
Phase Phase 4
First received September 14, 2005
Last updated October 27, 2005
Start date April 2005
Est. completion date July 2005

Study information
Verified date July 2004
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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 therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sirolimus, mycophenolat mofetil, fluvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Schleswig-Holstein
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