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OPTIMIZE: Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02161237
Collaborator
(none)
73
Enrollment
2
Locations
2
Arms
29.9
Actual Duration (Months)
36.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.
Actual Study Start Date :
Jun 26, 2014
Actual Primary Completion Date :
Dec 22, 2016
Actual Study Completion Date :
Dec 22, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: standard dose group

Oral

Drug: Advagraf®
oral
Other Names:
  • FK506
  • tacrolimus

    		•
    Experimental: optimized dose group

    Oral

    Drug: Advagraf®
    oral
    Other Names:
  • FK506
  • tacrolimus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. estimated GFR [at Week-52 after transplantation]

    Secondary Outcome Measures

    1. creatinine clearance [at Week-52 after transplantation]

    2. serum creatinine level [at Week-52 after transplantation]

    3. Number of graft survival [at Week-52 after transplantation]

    4. Subject survival [at Week-52 after transplantation]

    5. number of biopsy-proven acute rejection [at Week-52 after transplantation]

    6. Composite of graft loss, subject death and biopsy proven acute rejection [at Week-52 after transplantation]

    7. Time to the first acute rejection [up to Week-52 after transplantation]

    8. Time to the first steroid-resistant acute rejection [up to Week-52 after transplantation]

    9. Severity of biopsy proven acute rejection [up to Week-52 after transplantation]

      Severity is evaluated using Banff '07 Criteria

    10. Safety assessed by the incidence of adverse events, vital signs and lab tests [for 52 weeks after transplantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation

    • Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type

    • Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study

    Exclusion Criteria:

    • Receiving or having previously received an organ transplant other than a kidney

    • Cold ischemia time of the donor kidney > 24 hours

    • Receiving a graft from a non-heart-beating donor other than of Maastricht category 3

    • Significant liver disease

    • Receiving a graft from a hepatitis C or B positive donor

    • Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy

    • Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer

    • Subject or donor known to be HIV positive

    • Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient

    • Subject has malignant tumor

    • Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study

    • Subject with a high immunological risk

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Medical Director, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT02161237
    Other Study ID Numbers:
    • 506-MA-1001
    First Posted:
    Jun 11, 2014
    Last Update Posted:
    Mar 5, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Astellas Pharma Inc
    Acute rejection
    Advagraf
    Renal function
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Mar 5, 2019