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

 -  Participated in one of the selected Astellas sponsored clinical trials :

 -  DIAMOND - PMR-EC-1106

 -  ADVANCE - PMR-EC-1211

 -  ADHERE - PMR-EC-1212

 -  Or, any potential new Astellas-sponsored Advagraf trial

 -  Assigned to treatment with Advagraf in one of the selected Astellas sponsored clinical
 trials and received a kidney or liver organ transplant.

 NOTE: The primary objective is to study long-term graft survival in patients currently or
 previously treated with Advagraf. Therefore patients do not have to be currently receiving
 Advagraf to be included, nor do they have to have completed a previous Astellas clinical
 trial.

 Exclusion Criteria:

 -  No exclusion criteria