NCT01332201

Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®

A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

Conditions

• Heart Transplantation
• Lung Transplantation
• Pancreas (Including SPK) Transplantation

Interventions

Type	Name	Description
DRUG	Advagraf	oral
DRUG	Prograf	oral

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-04-11
• Last updated: 2015-06-16

Locations

8 sites across 6 countries: Austria, Belgium, France, Italy, Taiwan, United Kingdom