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

Astellas

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: tacrolimus; Drug: Tacrolimus Modified Release (MR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282568

02-0-131

Details and patient eligibility

About

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

Full description

This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a 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 kidney 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 kidney
• 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 Modified Release

Experimental group

Description:

Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.

Treatment:

Drug: Tacrolimus Modified Release (MR)

Drug: tacrolimus