Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation
OPTIMIZE
A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.
1 other identifier
interventional
73
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2014
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2014
CompletedFirst Posted
Study publicly available on registry
June 11, 2014
CompletedStudy Start
First participant enrolled
June 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2016
CompletedOctober 31, 2024
October 1, 2024
2.5 years
June 9, 2014
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
estimated GFR
at Week-52 after transplantation
Secondary Outcomes (10)
creatinine clearance
at Week-52 after transplantation
serum creatinine level
at Week-52 after transplantation
Number of graft survival
at Week-52 after transplantation
Subject survival
at Week-52 after transplantation
number of biopsy-proven acute rejection
at Week-52 after transplantation
- +5 more secondary outcomes
Study Arms (2)
standard dose group
EXPERIMENTALOral
optimized dose group
EXPERIMENTALOral
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Seoul, South Korea
Unknown Facility
Taipei, Taiwan
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2014
First Posted
June 11, 2014
Study Start
June 26, 2014
Primary Completion
December 22, 2016
Study Completion
December 22, 2016
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.