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NCT00223015 Clinical Trial

Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation

Renal Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00223015
Other study ID # 002
Secondary ID
Status Completed
Phase Phase 4
First received September 14, 2005
Last updated October 19, 2005
Start date May 2004
Est. completion date April 2005

Study information
Verified date May 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

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

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date April 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: 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)

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Fluvastatin, Tacrolimus, Mycophenolat Mofetil

Locations
Country Name City State
n/a

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