Kidney Transplant
Conditions
Keywords
Immunosuppressive regimen, Advagraf, kidney transplant, Corticosteroid
Brief summary
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
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.
Interventions
DRUGAdvagraf
oral
DRUGCorticosteroid
oral
Sponsors
Astellas Pharma Korea, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the GFR before the treatment (baseline) to that on Week 24 | Baseline and Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in the GFR before the treatment (baseline) to that on Week 12 | Baseline and Week 12 |
| Physical examinations including cyclosporine related cosmetic side effect | Up to Week 24 |
Countries
South Korea
Outcome results
None listed