A Phase 4 interventional study of Advagraf and Corticosteroid in Kidney Transplant, sponsored by Astellas Pharma Korea, Inc.. Completed at 9 sites in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Astellas Pharma Korea, Inc. (part of Astellas Pharma Inc) · Phase 4, Interventional, and Treatment
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.
Astellas Pharma Korea, Inc. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
oral
Drug: Advagraf · Drug: Corticosteroid
oral
Drug: Advagraf · Drug: Corticosteroid
oral
oral
Change in the GFR before the treatment (baseline) to that on Week 24
Time frame: Baseline and Week 24
Change in the GFR before the treatment (baseline) to that on Week 12
Time frame: Baseline and Week 12
Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24
Time frame: Baseline, Week 12 and Week 24
Incidence of acute rejection
Time frame: Up to Week 24
Safety assessed by the incidence of adverse events, vital signs and Lab-test
Time frame: Up to Week 24
Physical examinations including cyclosporine related cosmetic side effect
Time frame: Up to Week 24
Plan to share: No — 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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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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