Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients
This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
169
\- Orally, up to 1g BID(total 2g daily)
\- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml
\- Methyprednisolone 500mg / Prednisolone 5mg
Ajou University Hospital
Suwan, South Korea
DSA(Donor-specific Anti-HLA Antibody)
Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation
Time frame: 36 months
Incidence of composite efficacy failure
The frequency and percentage of composite efficacy failure (Treated-BPAMR \& ACR, graft loss, death and follow-up loss)
Time frame: 12, 24, 36months
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\- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)