Three-Year Outcomes From BENEFIT-EXT: A Phase III Study of Belatacept Versus Cyclosporine in Recipients of Extended Criteria Donor Kidneys

Three-Year Outcomes From BENEFIT-EXT: A Phase III Study of Belatacept Versus Cyclosporine in Recipients of Extended Criteria Donor Kidneys
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DOI:
10.1111/j.1600-6143.2011.03914.x
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发表时间:
2012-03-01
影响因子:
8.8
通讯作者:
Durrbach, A.
Durrbach, A.
中科院分区:
医学2区
文献类型:
--
作者:
Pestana, J. O. M.;Grinyo, J. M.;Durrbach, A.

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与标准标准供肾受者相比,扩展标准供肾 (ECD) 受者的长期预后较差。我们报告了一项随机 III 期研究的 3 年结果,该研究的受试者为新 ECD 肾脏受者 (n = 543),分配 (1:1:1) 为更高强度 (MI) 或更低强度 (LI) 贝拉西普方案或环孢素。到第 3 年,323 名患者完成了治疗。具有功能性移植物的患者存活率在各组之间相当(MI 组为 80%,LI 组为 82%,环孢素组为 80%)。贝拉西普治疗患者的平均计算 GFR (cGFR) 比环孢素治疗患者高 11 mL/min(MI 为 42.7,LI 为 42.2,环孢素为 31.5 mL/min)。更多环孢素治疗的患者 (44%) 进展为 GFR
Recipients of extended-criteria donor (ECD) kidneys have poorer long-term outcomes compared to standard-criteria donor kidney recipients. We report 3-year outcomes from a randomized, phase III study in recipients of de novo ECD kidneys (n = 543) assigned (1:1:1) to either a more intensive (MI) or less intensive (LI) belatacept regimen, or cyclosporine. Three hundred twenty-three patients completed treatment by year 3. Patient survival with a functioning graft was comparable between groups (80% in MI, 82% in LI, 80% in cyclosporine). Mean calculated GFR (cGFR) was 11 mL/min higher in belatacept-treated versus cyclosporine-treated patients (42.7 in MI, 42.2 in LI, 31.5 mL/min in cyclosporine). More cyclosporine-treated patients (44%) progressed to GFR