A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

Study Overview
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Brief Summary
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This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.

Detailed Description
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The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen. The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.

Official Title
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A Multicenter, Randomized, Comparison, Open-label, Phase IV Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: Advagraf
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation). Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment. The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment. GFR≥30 mL/min Exclusion Criteria: Had received an organ transplant other than a kidney Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully The subject received a kidney transplant from full-HLA identical donor Known to have FSGS or MPGN Type II as an underlying disease Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site Has liver cirrhosis

Ages Eligible for Study
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Minimum Age: 20 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: Corticosteroid with the 50% reduced dose<br>oral | Drug: Advagraf<br>* oral<br>Drug: Corticosteroid<br>* oral<br>|
| Active Comparator: Corticosteroid with the maintained dose<br>oral | Drug: Advagraf<br>* oral<br>Drug: Corticosteroid<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the GFR before the treatment (baseline) to that on Week 24 |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the GFR before the treatment (baseline) to that on Week 12 |  | Baseline and Week 12 | 
| Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24 |  | Baseline, Week 12 and Week 24 | 
| Incidence of acute rejection |  | Up to Week 24 | 
| Safety assessed by the incidence of adverse events, vital signs and Lab-test |  | Up to Week 24 | 
| Physical examinations including cyclosporine related cosmetic side effect |  | Up to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advagraf, Immunosuppressive regimen, kidney transplant, Corticosteroid