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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplantation
• Liver Transplantation
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	FK506E	oral

Timeline

• Start date: 2003-02-24
• Primary completion: 2009-10-07
• Completion: 2009-10-07
• First posted: 2014-04-21
• Last updated: 2024-11-22
• Results posted: 2016-03-15

Locations

105 sites across 23 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom