The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
206
Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8ng/mL
Up to 1g BID(total 2g daily), PO
Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea
Seoul, South Korea
Incidence of composite efficacy failure
Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Time frame: Until 24 weeks
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
The frequency and Incidence
Time frame: Until 24 weeks
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
By Banff classification categories
Time frame: Until 24 weeks
Survival rate of transplanted organ
Kaplan-Meier
Time frame: Until 24 weeks
Survival rate of Patients
Kaplan-Meier
Time frame: Until 24 weeks
Serum-Cr, eGFR
eGFR using MDRD
Time frame: Until 24 weeks
Incidence of BKV, CMV infection
The frequency and Incidence
Time frame: Until 24 weeks
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