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

Astellas

Status

Completed

Conditions

Kidney Transplant

Liver Transplant

Treatments

Drug: Tacrolimus

Study type

Observational

Funder types

Industry

Identifiers

NCT02057484

PMR-EC-1213

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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