신장이식 1개월 이후 Everolimus (CerticanⓇ) 및 저용량 Cyclosporine 면역억제 요법의 유효성 및 안전성을 평가하기 위한 공개, 비교, 평행, 다기관 임상연구 : 중간 연구 보고

Abstract

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.