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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 ®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid with the 50% reduced dose | Experimental | oral |
|
| Corticosteroid with the maintained dose | Active Comparator | oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advagraf | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the GFR before the treatment (baseline) to that on Week 24 | Baseline and Week 24 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan | South Korea | |||||
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| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| Corticosteroid | Drug | oral |
|
| 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 |
| Chungcheongnam-do |
| South Korea |
| Daegu | South Korea |
| Gyeonggi-do | South Korea |
| Incheon | South Korea |
| Jeollabuk-do | South Korea |
| Jeollanam-do | South Korea |
| Seoul | South Korea |
| Ulsan | South Korea |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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