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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 : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

Brief Summary:
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.

Condition or disease Intervention/treatment
Liver Transplant Kidney Transplant Drug: Tacrolimus

Detailed 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.


Study Type : Observational
Actual Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Group/Cohort Intervention/treatment
Organ transplant patients treated with Advagraf
To evaluate long-term graft survival in patients treated with Advagraf
Drug: Tacrolimus
oral
Other Name: Advagraf




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who had previously participated in the following Astellas sponsored clinical trial also known as "feeder trials":

DIAMOND / PMR-EC1106 ADVANCE / PMR-EC-1211 ADHERE / PMR-EC-1212 Any potential new Astellas-sponsored Advagraf trial

Criteria

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

Information from the National Library of Medicine

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


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Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Medical Director Astellas Pharma Europe Ltd.

Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT02057484     History of Changes
Other Study ID Numbers: PMR-EC-1213
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
long-term follow-up
liver transplant
kidney transplant
Advagraf
Tacrolimus

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action