신장이식 1개월 이후 Everolimus (CerticanⓇ) 및 저용량 Cyclosporine
면역억제 요법의 유효성 및 안전성을 평가하기 위한 공개, 비교, 평행, 다기관
임상연구 : 중간 연구 보고
Safety and Efficacy of the Early Introduction of Everolimus (Certican®) with Low Dose of Cyclosporine in de Novo Kidney Recipients after 1 Month of Transplantation (Preliminary Results)
오창권 ; 하종원 ; 김유선 ; 김용림 ; 김영훈
대한이식학회지, Vol.26(2) : 83~91, 2012
Background: Everolimus and cyclosporine (CsA) exhibit synergistic immunosuppressive activity when used in combination.
We analyzed preliminary data about the use of everolimus with a CsA-sparing strategy in de novo renal transplant recipients.
Methods: A comparative, parallel, randomized, open-label, 1 year study has been performed in 117 patients from 5 transplant
centers to compare the efficacy and tolerability of everolimus (EVE)＋reduced-dose CsA or enteric-coated mycophenolate
sodium (Myfortic)＋standard-dose CsA in combination with basiliximab and steroids. It ended on August 24, 2011. Efficacy
failure (biopsy-proven acute rejection, death, graft loss, or loss to follow-up), safety, and renal function were evaluated at
1, 3, 5, and 12 months post-transplantation.
Results: Efficacy failure was comparable between the two groups. Only one graft loss has been reported in the control group
and no patient death reported in either group. There was no significant difference in the incidence of biopsy-proven acute
rejection until 3 and 5 month post-transplantation (P＞0.05). The mean e-GFR of the group of EVE＋reduced-dose CsA was
significantly higher than that of the control group at 3 (65.6±16.9 mL/mim/1.73 m2 vs. 56.7±14.4 mL/mim/1.73 m2; P=0.007)
and 5 (68.6±18.8 mL/mim/1.73 m2 vs. 58.1±16.2 mL/mim/1.73 m2; P=0.009) months. There was no significant difference in
the incidence of discontinuations and serious adverse events between the groups (P＞0.05).
Conclusions: The regimen of EVE＋reduced-dose CsA seems to be tolerated well, with comparable efficacy failure and better
renal function than enteric-coated mycophenolate sodium＋standard-dose CsA.