Conditions: Heart Transplantation Liver Transplantation Kidney Transplantation
Keywords: FK506E Heart Transplantation MR4 Tacrolimus Advagraf Kidney Transplantation Renal Transplantation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 850
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Arms:
arm 1: 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.

Interventions: intervention 1: FK506E
Intervention descriptions: intervention 1: oral

Protocol document: