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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

Kidney Transplantation Clinical Trial

Official title:
A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02118896
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 3
Start date February 24, 2003
Completion date October 7, 2009
View Details
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