NCT02057484

A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

A Long-term Follow-up of Adult Kidney and Liver Allograft Recipients Previously Enrolled Into a Tacrolimus (Advagraf) Trial. A Multicentre Non-interventional Post Authorization Study (PAS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,300 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

Detailed description

Prograf is one of the medications taken by a patient after they have had a liver or kidney transplant to prevent their body from rejecting the new liver or kidney transplant. Prograf is taken by the patient twice a day. Advagraf is a similar medication but is taken by the patient only once a day. There is some evidence emerging that may show that this once-a-day medication may show additional benefits over the twice a day medication, such as, patients more likely to remember to take this medication. Also, this once a day medication is slowly released in the body through the course of a day which in turn may provide better protection against the body rejecting the new transplanted organ over a longer period. This study will follow up adult patients who were previously enrolled in an Advagraf trial after they have had a liver or kidney transplant. The information collected for this study will be information that the patient's doctor will normally collect when he/she sees the patient for their regular check-ups. Information will be collected once a year for a period of 5 years from when the patient received their new organ transplant. It is hoped that patient information collected during the study will provide prescribers with useful information in treatment of organ transplant patients.

Conditions

• Liver Transplant
• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Tacrolimus	oral

Timeline

• Start date: 2014-03-03
• Primary completion: 2017-10-17
• Completion: 2017-10-17
• First posted: 2014-02-07
• Last updated: 2024-10-31

Locations

145 sites across 24 countries: Austria, Belarus, Belgium, Canada, Czechia, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, United Kingdom