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

Sponsor

University Hospital Schleswig-Holstein (Other)

Overall Status

Completed

CT.gov ID

NCT00223015

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

May 1, 2004

Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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