drugset
drugset / Trial / NCT02118896

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

NCT02118896 ↗

Phase 3 Completed 850 enrolled Astellas Pharma Europe Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2003-02-24
Primary completion
2009-10-07
Completion
2009-10-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.5 mg Oral
Subject Tacrolimus Small molecule 1 mg Oral
Subject Tacrolimus Small molecule 5 mg Oral

Indications

No indication recorded.