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.
Study Type
OBSERVATIONAL
Enrollment
2,300
oral
Overall graft survival (time to graft loss)
At each annual visit there will be a simple assessment to determine if the graft has survived or not.
Time frame: Annually from date of transplant and for 5 five years
Overall patient survival
At each annual visit there will be a simple assessment to determine if the patient has survived or not.
Time frame: Annually from date of transplant and for 5 five years
Renal Function
At each annual visit serum creatinine results, which is part of routine clinical practice will be collected from the patient's medical records. This will be used by the sponsor to calculate estimated glomerular filtration rate.
Time frame: Annually from date of transplant and for 5 five years
Emergence of de novo Donor Specific Antibody
If the site collects this information as part of routine clinical practice, only then will this information be collected.
Time frame: Annually from date of transplant and for 5 five years
Biopsy proven acute rejection episodes
All rejection episodes captured in the medical records of the patient from one annual visit to the next will be collected for this study
Time frame: Annually from date of transplant and for 5 five years
Immunosuppression regimen
Any immunosuppression regimen, doses and changes in doses from one annual visit to another, as well any annual trough levels of tacrolimus.
Time frame: Annually from date of transplant and for 5 five years
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Site AT43001
Innsbruck, Austria
Site AT43003
Linz, Austria
Site AT43002
Vienna, Austria
Site BY37501
Minsk, Belarus
Site BE32007
Brussels, Brussels Capital, Belgium
Site BE32002
Brussels, Belgium
Site BE32001
Ghent, Belgium
Site BE32003
Leuven, Belgium
Site BE32005
Leuven, Belgium
Site BE32008
Liège, Belgium
...and 135 more locations
Medical conditions of interest
Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes.
Time frame: Annually from date of transplant and for 5 five years
Infections of interest
Infections of interest include cytomegalovirus and BK virus
Time frame: Annually from date of transplant and for 5 five years