A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant (ADDRESS)
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|ClinicalTrials.gov Identifier: NCT02057484|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : December 28, 2018
|Condition or disease||Intervention/treatment|
|Liver Transplant Kidney Transplant||Drug: Tacrolimus|
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|
|Actual Enrollment :||2300 participants|
|Official Title:||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)|
|Actual Study Start Date :||March 3, 2014|
|Actual Primary Completion Date :||October 17, 2017|
|Actual Study Completion Date :||October 17, 2017|
Organ transplant patients treated with Advagraf
To evaluate long-term graft survival in patients treated with Advagraf
Other Name: Advagraf
- Overall graft survival (time to graft loss) [ Time Frame: Annually from date of transplant and for 5 five years ]At each annual visit there will be a simple assessment to determine if the graft has survived or not.
- Overall patient survival [ Time Frame: Annually from date of transplant and for 5 five years ]At each annual visit there will be a simple assessment to determine if the patient has survived or not.
- Renal Function [ Time Frame: Annually from date of transplant and for 5 five years ]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.
- Emergence of de novo Donor Specific Antibody [ Time Frame: Annually from date of transplant and for 5 five years ]If the site collects this information as part of routine clinical practice, only then will this information be collected.
- Biopsy proven acute rejection episodes [ Time Frame: Annually from date of transplant and for 5 five years ]All rejection episodes captured in the medical records of the patient from one annual visit to the next will be collected for this study
- Immunosuppression regimen [ Time Frame: Annually from date of transplant and for 5 five years ]Any immunosuppression regimen, doses and changes in doses from one annual visit to another, as well any annual trough levels of tacrolimus.
- Medical conditions of interest [ Time Frame: Annually from date of transplant and for 5 five years ]Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes.
- Infections of interest [ Time Frame: Annually from date of transplant and for 5 five years ]Infections of interest include cytomegalovirus and BK virus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057484
|Study Director:||Medical Director||Astellas Pharma Europe Ltd.|