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Safety and efficacy of the early introduction of everolimus with reduced-exposure cyclosporine a in de novo kidney recipients

 Oh, Chang-Kwon  ;  Huh, Kyu Ha  ;  Ha, Jongwon  ;  Kim, Yeong Hoon  ;  Kim, Yong-Lim  ;  Kim, Yu Seun 
 TRANSPLANTATION, Vol.99(1) : 180-186, 2015 
Journal Title
Issue Date
Acute Disease ; Adult ; Antibodies, Monoclonal/administration & dosage ; Calcineurin Inhibitors/administration & dosage* ; Calcineurin Inhibitors/adverse effects ; Cyclosporine/administration & dosage* ; Cyclosporine/adverse effects ; Drug Therapy, Combination ; Everolimus ; Female ; Graft Rejection/diagnosis ; Graft Rejection/immunology ; Graft Rejection/prevention & control* ; Graft Survival/drug effects* ; Humans ; Immunosuppressive Agents/administration & dosage* ; Immunosuppressive Agents/adverse effects ; Kidney Transplantation*/adverse effects ; Male ; Middle Aged ; Mycophenolic Acid/administration & dosage ; Mycophenolic Acid/analogs & derivatives ; Prospective Studies ; Recombinant Fusion Proteins/administration & dosage ; Republic of Korea ; Sirolimus/administration & dosage ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives* ; Steroids/administration & dosage ; Time Factors ; Treatment Outcome
Kidney transplantation ; Everolimus ; Cyclosporine A
BACKGROUND: Everolimus and cyclosporine A (CsA) exhibit synergistic immunosuppressive activity when used in combination. We examined the safety and efficacy of the use of everolimus with a cyclosporine-sparing strategy in de novo renal transplant recipients. METHODS: A comparative, parallel, randomized, open-label 1-year study has been performed in 148 patients from five transplant centers to compare the efficacy and tolerability of everolimus and reduced exposure CsA (the investigational group) or enteric-coated mycophenolate sodium and standard-exposure CsA (the control group) in combination with basiliximab and steroids. The eligible subjects were randomly assigned at 1 month after transplantation. Efficacy failure (biopsy-proven acute rejection, death, graft loss, or loss to follow-up), safety, and renal function were evaluated. RESULTS: One graft loss has been reported in the control group and no patient death were reported in either group. The incidence of biopsy-proven acute rejection until 12 months after transplantation of the investigational group was 7.5%, compared to 11.1% of the control group (P=0.565). The mean estimated glomerular filtration rates of the investigational group at 12 months after transplantation was significantly higher (68.1 ± 16.8 ml/min/1.73 m(2)) than that of the control group (60.6 ± 15.8 ml/min/1.73 m(2); P=0.016). There was no significant difference (P>0.05) in the incidence of discontinuations and serious adverse events between the groups. CONCLUSION: The results of this study provide the evidences that (1) the calcineurin inhibitor (CNI) minimization by the introduction of everolimus after 1-month posttransplantation keeps the incidences of acute rejection and additional risks as low as the conventional immunosuppression; (2) it allows minimizing CNI exposure, consequently reducing CNI nephrotoxicity and preserving renal function.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yu Seun(김유선) ORCID logo https://orcid.org/0000-0002-5105-1567
Huh, Kyu Ha(허규하) ORCID logo https://orcid.org/0000-0003-1364-6989
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