The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/ml.
Up to 1g BID(total 2g daily), PO
Severance Hospital
Seoul, South Korea
Incidence of composite efficacy failure
Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure
Time frame: Until 48 weeks after taking medicine
Incidence of composite efficacy failure
Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure
Time frame: Until 24 weeks after taking medicine
Incidence of biopsy-confirmed acute rejection
Banff Criteria
Time frame: Until 24weeks and 48weeks after taking medicine
The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy
Banff Criteria
Time frame: Until 24weeks and 48weeks after taking medicine
Survival rate
transplanted organ and patients
Time frame: Until 24weeks and 48weeks after taking medicine
Function of Kidney
eGFR using MDRD(Modification of Diet in Renal Disease) method
Time frame: Until 24weeks and 48weeks after taking medicine
Incidence of CMV, BKV infection
Incidence of CMV, BKV infection
Time frame: Until 24weeks and 48weeks after taking medicine
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