-center, phase 2 clinical trial. A total of 225 primary transplant recipients of deceased-donor kidneys (KTx; 38.2% Black/African American, 44% White) were randomized to receive intravenous infliximab (IFX) 3 mg/kg or saline placebo (PLBO) initiated before kidney reperfusion. All patients received rabbit anti-thymocyte globulin induction and maintenance immunosuppression (IS) with tacrolimus, mycophenolate mofetil, and prednisone. The primary end point was the difference between groups in mean 24-month eGFR. Results There was no difference in the primary end point of 24-month eGFR between IFX (52.45 ml/min per 1.73 m2; 95% CI, 48.38 to 56.52) versus PLBO (57.35 ml/min per 1.73 m2; 95% CI, 53.18 to 61.52; P=0.1). There were no significant differences between groups in rates of delayed graft function, biopsy-proven acute rejection (BPAR), development of de novo donor-specific antibodies, or graft loss/death. Immunosuppression did not differ, and day 7 post-KTx plasma analyses showed approximately ten-fold lower TNF (P<0.001) in IFX versus PLBO. BK viremia requiring IS change occurred more frequently in IFX (28.9%) versus PLBO (13.4%; P=0.004), with a strong trend toward higher rates of BKV nephropathy in IFX (13.3%) versus PLBO (4.9%; P=0.06). Conclusions IFX induction therapy does not benefit recipients of kidney transplants from deceased donors on this IS regimen. Because the intervention unexpectedly increased rates of BK virus infections, our findings underscore the complexities of targeting peritransplant inflammation as a strategy to improve KTx outcomes. Clinical Trial registry name and registration number:clinicaltrials.gov (NCT02495077)....

中文翻译：

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英夫利昔单抗诱导缺乏疗效并增加已故供肾移植受者的 BK 病毒感染：CTOT-19 试验结果


-中心，2期临床试验。共有 225 名已故供体肾脏的初次移植受者（KTx；38.2% 黑人/非裔美国人，44% 白人）被随机分配接受静脉注射英夫利昔单抗 (IFX) 3 mg/kg 或盐水安慰剂 (PLBO)，然后再进行肾脏再灌注。所有患者均接受兔抗胸腺细胞球蛋白诱导和他克莫司、吗替麦考酚酯和泼尼松维持免疫抑制 (IS)。主要终点是组间平均 24 个月 eGFR 的差异。结果 IFX（每 1.73 m2 52.45 ml/min；95% CI，48.38 至 56.52）与 PLBO（每 1.73 m2 57.35 ml/min；95% CI，53.18）之间的 24 个月 eGFR 主要终点没有差异至 61.52；P=0.1)。移植物功能延迟、活检证实的急性排斥反应（BPAR）、从头供体特异性抗体的产生或移植物丢失/死亡的发生率在各组之间没有显着差异。免疫抑制没有差异，KTx 后第 7 天血浆分析显示，IFX 中的 TNF 较 PLBO 低约十倍（P<0.001）。需要改变 IS 的 BK 病毒血症在 IFX 中（28.9%）比 PLBO（13.4%；P=0.004）更频繁地发生，与 PLBO（4.9%；P=0.06）相比，IFX 中 BKV 肾病发生率有明显更高的趋势（13.3%） ）。结论 IFX 诱导治疗不会使采用该 IS 方案的已故捐献者肾移植受者受益。由于干预措施意外地增加了 BK 病毒感染率，因此我们的研究结果强调了以移植周围炎症为目标作为改善 KTx 结果的策略的复杂性。临床试验注册名称和注册号：clinicaltrials.gov (NCT02495077)....