Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation (OPTIMIZE)
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.
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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.
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Ages Eligible for Study:
20 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
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Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action