A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

Astellas

Status and phase: Completed; Phase 2

Conditions: Liver Transplantation

Treatments: Drug: tacrolimus; Drug: tacrolimus modified release (MR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282256

03-0-160

Details and patient eligibility

About

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.

Full description

A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

Enrollment: 19 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Tacrolimus MR

Experimental group

Description:

Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.

Treatment:

Drug: tacrolimus modified release (MR)

Drug: tacrolimus