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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Liver Transplant, Kidney Transplant

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Organ transplant patients treated with Advagraf<br>To evaluate long-term graft survival in patients treated with Advagraf | Drug: Tacrolimus<br>* oral<br>* Other names: Advagraf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Annually from date of transplant and for 5 five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patient survival | At each annual visit there will be a simple assessment to determine if the patient has survived or not. | 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. | 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. | 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 | 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. | Annually from date of transplant and for 5 five years | 
| Medical conditions of interest | Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes. | Annually from date of transplant and for 5 five years | 
| Infections of interest | Infections of interest include cytomegalovirus and BK virus | Annually from date of transplant and for 5 five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term follow-up, liver transplant, kidney transplant, Advagraf, Tacrolimus