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De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial

 Kyu Ha Huh  ;  Jae Geun Lee  ;  Jongwon Ha  ;  Chang-Kwon Oh  ;  Man Ki Ju  ;  Chan-Duck Kim  ;  Hong Rae Cho  ;  Cheol Woong Jung  ;  Beom Jin Lim  ;  Yu Seun Kim 
 Nephrology Dialysis Transplantation, Vol.32(8) : 1415-1424, 2017 
Journal Title
 Nephrology Dialysis Transplantation 
Issue Date
Case-Control Studies ; Dose-Response Relationship, Drug ; Equivalence Trials as Topic ; Female ; Glomerular Filtration Rate ; Graft Rejection/drug therapy ; Graft Rejection/etiology ; Humans ; Immunosuppressive Agents/therapeutic use ; Kidney Transplantation/adverse effects ; Male ; Middle Aged ; Mycophenolic Acid/therapeutic use ; Sirolimus/therapeutic use ; Tacrolimus/therapeutic use ; Time Factors
kidney transplantation ; mofetil ; mycophenolate ; post-transplant outcome ; sirolimus ; tacrolimus
Background: Most of the previous studies reported that tacrolimus (TAC) with sirolimus (SRL) was associated with worse post-transplant outcomes in kidney transplantation, compared with TAC with mycophenolate mofetil (MMF). These might be attributable to high-dose SRL. However, outcomes using low-dose SRL with TAC for kidney transplantation are uncertain. The aim of this study was to assess the efficacy and safety of low-dose SRL with extended-release tacrolimus (ER-TAC) versus MMF with ER-TAC. Methods: We randomly assigned 158 renal transplant patients to receive low-dose SRL or MMF in combination with ER-TAC and corticosteroid. The primary endpoint was the composite efficacy failure rate, including biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up, within 12 months post-transplantation. This trial is registered with ClinicalTrial.gov (number NCT01680952). Results: The efficacy failure rate was 6.6% in the low-dose SRL group and 13.3% in the MMF group in the intention-to-treat population (absolute difference, 6.8%; 95% confidence interval, -2.8% to 16.3%). The incidence of BPAR within 12 months post-transplantation was 5.3% in the low-dose SRL group and 13.3% in the MMF group (P = 0.09). The mean estimated glomerular filtration rate at 12 months post-transplantation was 53.2 mL/min/1.73 m2 in the low-dose SRL group and 52.4 mL/min/1.73 m2 in the MMF group (P = 0.76). The incidences of adverse events and serious adverse events were similar between groups. Conclusion: Low-dose SRL with ER-TAC was not inferior to MMF with ER-TAC with respect to efficacy and safety. When used for immunosuppression in kidney transplantation, low-dose SRL with ER-TAC can effectively prevent acute rejection and preserve renal function.
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1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
김유선(Kim, Yu Seun) ORCID logo https://orcid.org/0000-0002-5105-1567
이재근(Lee, Jae Geun) ORCID logo https://orcid.org/0000-0002-6722-0257
임범진(Lim, Beom Jin) ORCID logo https://orcid.org/0000-0003-2856-0133
주만기(Joo, Man Ki) ORCID logo https://orcid.org/0000-0002-4112-7003
허규하(Huh, Kyu Ha) ORCID logo https://orcid.org/0000-0003-1364-6989
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