Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

Astellas

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation; Kidney Transplantation; Heart Transplantation

Treatments: Drug: FK506E

Study type: Interventional

Funder types: Industry

Identifiers

NCT02118896

FG-506-14-02 (Other Identifier)

2005-005714-20 (EudraCT Number)

F506-CL-0857

Details and patient eligibility

About

The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

Full description

The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a long-term treatment in transplant recipients. Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled.

Enrollment: 850 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who had already participated in the previous phase II pharmacokinetic or phase III studies with FK506E (MR4).
• Patients capable of understanding the purpose and risks of the study, who had been fully informed and given written informed consent to participate in the study.

Exclusion criteria

• Pregnant women or nursing mothers.
• Women unwilling or unable to use adequate contraception during the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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850 participants in 1 patient group

1: FK506E (MR4)

Experimental group

Description:

Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective immunosuppression. MR4 capsules were taken orally, once daily in the morning. MR4 capsules were to be swallowed with fluid (preferably water) on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. MR4 was supplied as 0.5 mg, 1 mg and 5 mg capsules in amber glass bottles or in blister packs.

Treatment:

Drug: FK506E