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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Advagraf®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard dose group<br>Oral | Drug: Advagraf®<br>* oral<br>* Other names: tacrolimus;|
| Experimental: optimized dose group<br>Oral | Drug: Advagraf®<br>* oral<br>* Other names: tacrolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimated GFR |  | at Week-52 after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Composite of graft loss, subject death and biopsy proven acute rejection |  | at Week-52 after transplantation | 
| Time to the first acute rejection |  | up to Week-52 after transplantation | 
| Time to the first steroid-resistant acute rejection |  | up to Week-52 after transplantation | 
| Severity of biopsy proven acute rejection | Severity is evaluated using Banff '07 Criteria | up to Week-52 after transplantation | 
| Safety assessed by the incidence of adverse events, vital signs and lab tests |  | for 52 weeks after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute rejection, Advagraf, Renal function