Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects (Maple)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01882322
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

Brief Summary:
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.

Condition or disease Intervention/treatment Phase
de Novo Liver Transplant Subjects Drug: Prograf Drug: Advagraf Phase 4

Detailed Description:
De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Advagraf® (Modified Release Tacrolimus, Once Daily) After Using Prograf® (Tacrolimus Twice Daily) in de Novo Liver Transplant Recipients
Actual Study Start Date : January 30, 2013
Actual Primary Completion Date : January 3, 2017
Actual Study Completion Date : January 3, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Advagraf conversion group
Oral
Drug: Prograf
oral
Other Name: Tacrolimus

Drug: Advagraf
oral
Other Name: modified release Tacrolimus

Active Comparator: Prograf maintenance group
Oral
Drug: Prograf
oral
Other Name: Tacrolimus




Primary Outcome Measures :
  1. Incidence of biopsy-confirmed acute rejection [ Time Frame: from Week 4 to Week 24 post-transplant ]
    Acute rejection incidence (%) = Number of subjects with at least one biopsy -confirmed acute rejection / Total number of subjects included in the relevant analysis set * 100


Secondary Outcome Measures :
  1. Incidence of biopsy-confirmed acute rejection [ Time Frame: from Week 4 to Week 12 or Week 24 ]
  2. Severity of biopsy-confirmed acute rejection [ Time Frame: from Week 4 to Week 12 and Week 24 after liver transplant ]
    Severity guideline is Banff criteria

  3. Subject survival rate and graft survival rate [ Time Frame: from Week 4 to Week 12 and Week 24 after liver transplant ]
  4. Safety assessed by the incidence of adverse events, vital signs, physical exam. and labo-tests [ Time Frame: for 24 weeks after liver transplant ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A subject scheduled for liver transplantation from a living donor or brain dead
  • In case of a woman of childbearing potential, a subject with a negative pregnancy test prior to enrollment and who consents to and would practice double contraception throughout the study (Pessary therapy, or rhythm method, or sexual abstinence, surgical sterilization, menopause or otherwise sterile; however, oral contraceptives are excluded.)
  • A subject with terminal hepatic failure for which liver transplant is necessary
  • A subject who understands and is completely aware of the study objective and risks and who submitted a written informed consent form on study participation

Exclusion Criteria:

  • A subject who received multiple organ transplants or any previous organ transplant (including re-transplantation of the liver)
  • A subject who had received auxiliary transplant or used the bioartificial liver (cellular system)
  • A subject allergic or resistant to macrolide antibiotics or Tacrolimus
  • A subject who was taking Cyclosporine and Bosentan (Tracleer) that may interact with Tacrolimus, or potassium-sparing diuretics known to possibly cause hyperkalemia (Spironolactone, Triamterene) at screening
  • A subject who requires immunosuppressive treatment or systemic chemotherapy from before transplant. However, a subject who received immunosuppressive treatment for less than 1 month prior to transplant to treat underlying hepatic disorder may be enrolled in the study if treatment is discontinued at the time of transplant.
  • A subject with malignancy or malignant tumor history within the past 5 years; however, a subject may be enrolled in this study in case of successfully cured for basal cell carcinoma or squamous cell carcinoma of the skin.
  • A subject who suffers severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect Tacrolimus absorption (may be determined at the discretion of the investigator)
  • A subject with any type of substance abuse, psychological disorder, or communication disorder at the discretion of the investigator
  • A subject who is participating in another study or participated within 28 days of the study, or who had received IP or non-registered medication
  • A subject who is pregnant or breastfeeding
  • A subject (transplant recipient) and/or donor who are positive to HIV
  • A subject who cannot comply with the protocol-planned routine visit schedule
  • A subject who is not appropriate for study participation at the discretion of the investigator

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): NCT01882322


Locations
Layout table for location information
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Layout table for additonal information
Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT01882322     History of Changes
Other Study ID Numbers: ADV-LT-01
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
FK506
tacrolimus
immunosuppressant

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