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

Astellas

Status and phase: Completed; Phase 2

Conditions: Liver Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282243

02-0-152

Details and patient eligibility

About

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.

Full description

A one arm 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 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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70 participants in 1 patient group

Tacrolimus MR

Experimental group

Description:

After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study. Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons.

Treatment:

Drug: tacrolimus

Drug: tacrolimus modified release (MR)