A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric 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 pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Key facts

Study ID

NCT00282256

Run by

Astellas Pharma Inc

People needed

19

Starts

2004-01-01

Expected to finish

2008-10-01

Last updated by the study team

2013-10-17

Who can join

Age: any, up to 12. 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 — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — New York, New York, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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