NCT01882322

A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects

A Phase IV, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Advagraf® (Modified Release Tacrolimus, Once Daily) After Using Prograf® (Tacrolimus Twice Daily) in de Novo Liver Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.

Detailed description

De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.

Conditions

• de Novo Liver Transplant Subjects

Interventions

Type	Name	Description
DRUG	Prograf	oral
DRUG	Advagraf	oral

Timeline

• Start date: 2013-01-30
• Primary completion: 2017-01-03
• Completion: 2017-01-03
• First posted: 2013-06-20
• Last updated: 2024-10-31

Locations

1 site across 1 country: South Korea