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

• Status: Completed
• Trial end date: 2009-10-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Treatments: Tacrolimus

Criteria

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.