The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.
This is a 6-month, single-arm, multi-center, open-label, continuous cohort study. 160 subjects who had kidney transplantations at least 3 months earlier will participate in the study. All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed. advagrf+sirolimus one time to eat.
Nephrology, Pusan National University Hospital
Busan, South Korea
Bundang CHA Medical Center,
Gyeonggi-do, South Korea
Inje University Ilsan Paik Hospital
Gyeonggido, South Korea
Korea University Medical Center
Seoul, South Korea
acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up
The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up).
Time frame: 6months
renal functions
Difference in renal functions (eGFR by MDRD method), urine protein excretion and P/C ratio (A/C ratio), transplant kidney biopsy histology (if biopsy is performed).
Time frame: 6months
serious adverse events
Frequency and severity of adverse events and serious adverse events
Time frame: 6months
cardiovascular health
Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).
Time frame: 6months
NODAT
Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.
Time frame: 6months
hematology issue
Frequency of anemia, leucopenia, and thrombocytopenia.
Time frame: 6months
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Severance Hospital
Seoul, South Korea
Soonchunhyang University Hosptial
Seoul, South Korea
Dept. of Surgery, Ulsan University Hospital
Ulsan, South Korea