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Completed

NCT Number: NCT02057484

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.

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Key information

Conditions

Liver Transplant Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site AT43001, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: Advagraf

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. Infections of interest

    Time frame: Annually from date of transplant and for 5 five years

    Infections of interest include cytomegalovirus and BK virus

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study 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)

Acronym: ADDRESS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2014
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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