To investigate the efficacy, safety, and drug compliance of Advagraf® (Extended Release Tacrolimus) by comparing the Advagraf® + steroid + Mycophenolate Mofetil combined therapy and the Prograf® + steroid + Mycophenolate Mofetil combined therapy in de novo kidney recipients 1 month after kidney transplantation.
This study is a multicenter, open-label, randomized, parallel, and comparative clinical trial. All the enrolled subjects will be treated with Prograf® (Tacrolimus), Basilixumab, Corticosteroids, and Mycophenolate Mofetil to suppress their immune system for one month (30 days) after their kidney transplant. After the one month, the experimental group (30 subjects) will be treated with Advagraf® (Extended Release Tacrolimus) instead of Prograf® (Tacrolimus), and the Corticosteroids and Mycophenolate Mofetil will be maintained. The control group (30 subjects) will continuously receive Prograf® (Tacrolimus), Corticosteroids, and Mycophenolate Mofetil. The clinical progress of the subjects in the experimental and control groups up to six months after their transplant will be investigated and compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Unnamed facility
Seoul, South Korea
Unnamed facility
Suwon, South Korea
Unnamed facility
Ulsan, South Korea
Incidence of efficacy failure (treated-BCAR, biopsy-confirmed acute rejection, graft loss rate, death, or follow-up failure)
Time frame: until 6 months
Survival rate
Time frame: at 6 months after treatment
Kidney function (eGFR)
assessment of eGFR using the Nankivell method
Time frame: at 6 months
24-hour urine protein and creatinine clearance rate(CCR)
Time frame: at 6 months
Incidence of new-onset diabetes after kidney transplantation (NODAT)
Time frame: until 6 months
Safety assessed by the incidence of adverse events, physical exam, and labo-tests
Time frame: until 6 months
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