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MAIN: A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01339468
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
37
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients
Actual Study Start Date :
Apr 27, 2011
Actual Primary Completion Date :
May 27, 2014
Actual Study Completion Date :
May 27, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Intravenous Prograf therapy followed by oral Advagraf therapy

Drug: Advagraf
oral
Other Names:
  • FK506E
  • modified release tacrolimus

    • Drug: Prograf
    intravenous
    Other Names:
  • tacrolimus
  • FK506

    		•
    Active Comparator: Arm 2

    Intravenous Prograf therapy followed by oral Prograf therapy

    Drug: Prograf
    oral
    Other Names:
  • FK506
  • tacrolimus

    • Drug: Prograf
    intravenous
    Other Names:
  • tacrolimus
  • FK506

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration [Day 6 and day 21]

    Secondary Outcome Measures

    1. Cmax (maximum concentration) of tacrolimus plasma concentration [Day 6 and day 21]

    2. Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) [up to 24 weeks]

    3. Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) [up to 24 weeks]

    4. Safety assessed by the incidence of adverse events and lab-tests [up to 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • subject receiving a primary, partial liver graft from a living donor

    • subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined

    Exclusion Criteria:

    • subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)

    • subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used

    • subjects allergic or intolerant to macrolide antibiotics or tacrolimus

    • subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation

    • subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin

    • subjects with systemic infection requiring treatment, except viral hepatitis

    • subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus

    • subjects with serum creatinine > 1.5mg/dl

    • subjects taking or having taken potassium preserved diuretics

    • subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator

    • subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days

    • subjects or donors known to be HIV positive

    • donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul Korea, Republic of

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01339468
    Other Study ID Numbers:
    • MR-08-04-KOR_Main
    First Posted:
    Apr 20, 2011
    Last Update Posted:
    Jul 19, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Astellas Pharma Inc
    advagraf
    prograf
    living donor liver transplantation
    FK506
    Immunosuppressant
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Jul 19, 2017