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

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ClinicalTrials.gov Identifier: NCT02161237
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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
Kidney Transplantation Drug: Advagraf® Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : June 26, 2014
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : December 22, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. estimated GFR [ Time Frame: at Week-52 after transplantation ]

Secondary Outcome Measures :
  1. creatinine clearance [ Time Frame: at Week-52 after transplantation ]
  2. serum creatinine level [ Time Frame: at Week-52 after transplantation ]
  3. Number of graft survival [ Time Frame: at Week-52 after transplantation ]
  4. Subject survival [ Time Frame: at Week-52 after transplantation ]
  5. number of biopsy-proven acute rejection [ Time Frame: at Week-52 after transplantation ]
  6. Composite of graft loss, subject death and biopsy proven acute rejection [ Time Frame: at Week-52 after transplantation ]
  7. Time to the first acute rejection [ Time Frame: up to Week-52 after transplantation ]
  8. Time to the first steroid-resistant acute rejection [ Time Frame: up to Week-52 after transplantation ]
  9. Severity of biopsy proven acute rejection [ Time Frame: 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 [ Time Frame: for 52 weeks after transplantation ]


Information from the National Library of Medicine

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

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

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): NCT02161237


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02161237    
Other Study ID Numbers: 506-MA-1001
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/
Keywords provided by Astellas Pharma Inc:
Acute rejection
Advagraf
Renal function
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action