A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients

Completed · Phase 2

Conditions studied: Liver Transplantation

In brief

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Key facts

Study ID

NCT00282243

Run by

Astellas Pharma Inc

People needed

70

Starts

2003-02-01

Expected to finish

2008-10-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is currently receiving Prograf ® based immunosuppressive therapy for liver transplantation.
• Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

You may not qualify if…

• Patient has previously received an organ transplant other than a liver
• Patient is currently receiving sirolimus immunosuppression therapy.

Where it is running

• Study site — Palo Alto, California, United States
• Study site — Denver, Colorado, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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