INTRODUCTION Accumulation of β2-microglobulin (B2M) in dialysis patients contributes to several comorbidities of end-stage kidney disease (ESKD). The LIXELLE® device adsorbs B2M from blood using sorbent bead technology. Studies in Japan showed that LIXELLE treatment during hemodialysis (HD) at blood flow rates up to 250 mL/min removes B2M above HD alone and is well tolerated. We investigated tolerance for LIXELLE treatment during HD at higher HD blood flow rates standard in the USA. METHODS A prospective, open-label, non-randomized, single-arm, early-feasibility study (EFS) assessed tolerance and safety of LIXELLE treatment during HD at blood flow rates up to 450 mL/min. ESKD patients (40-75 years old) on thrice weekly outpatient HD were eligible. After a 1-week HD run-in, patients received LIXELLE plus HD at a blood flow rate of 250 mL/min (1 week), followed by LIXELLE plus HD at a blood flow rate up to 450 mL/min (1 week). These blood flow rates were tested with three LIXELLE column sizes in sequence (treatment = 6 weeks). B2M removal was assessed for each combination. RESULTS Ten patients with a historic intradialytic hypotension (IDH) rate of 0.42 events/HD session/patient were enrolled. Nine patients completed all combinations without IDH events (treatment IDH rate: 0.56 events/HD session/patient). No treatment-emergent serious adverse events or significant changes in red blood cell, platelet, or complement indices except haptoglobin were reported. B2M reduction ratios and removal of select proteins (<40 kDa) increased with escalating column size and blood flow rate. CONCLUSION LIXELLE plus HD across all column sizes was safe and well tolerated at blood flow rates up to 450 mL/min. Extent of B2M removal corresponded to column size-blood flow rate combinations. This EFS provides a risk profile to guide further studies of LIXELLE in ESKD patients at US-standard blood flow rates.

中文翻译：

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门诊血液透析期间体外血流量对患者对 LIXELLE® 治疗耐受性的影响。


简介 透析患者体内 β2-微球蛋白 (B2M) 的积累会导致终末期肾病 (ESKD) 的多种合并症。 LIXELLE® 装置利用吸附剂珠技术从血液中吸附 B2M。日本的研究表明，在血液透析 (HD) 期间，以高达 250 mL/min 的血流量进行 LIXELLE 治疗可消除高于单独 HD 的 B2M，并且耐受性良好。我们在美国以较高的 HD 血流速率标准研究了 HD 期间 LIXELLE 治疗的耐受性。方法 一项前瞻性、开放标签、非随机、单臂、早期可行性研究 (EFS) 评估了 HD 期间血流速率高达 450 mL/min 时 LIXELLE 治疗的耐受性和安全性。每周三次门诊 HD 的 ESKD 患者（40-75 岁）符合资格。经过 1 周的 HD 磨合后，患者以 250 mL/min 的血流量（1 周）接受 LIXELLE 加 HD 治疗，随后以高达 450 mL/min 的血流量接受 LIXELLE 加 HD（1 周） 。这些血流速率依次用三种 LIXELLE 柱尺寸进行测试（治疗 = 6 周）。对每种组合的 B2M 去除进行了评估。结果 10 名历史性透析中低血压 (IDH) 发生率为 0.42 次/HD 疗程/患者的患者纳入研究。 9 名患者完成了所有组合，没有发生 IDH 事件（治疗 IDH 发生率：0.56 事件/HD 疗程/患者）。没有报告治疗引起的严重不良事件或红细胞、血小板或补体指数（触珠蛋白除外）的显着变化。 B2M 减少率和选择蛋白质 (<40 kDa) 的去除率随着柱尺寸和血流量的增加而增加。结论 LIXELLE plus HD 在所有尺寸的色谱柱上都是安全的，并且在血流量高达 450 mL/min 时具有良好的耐受性。 B2M 去除程度与柱尺寸-血液流速组合相对应。 该 EFS 提供了风险概况，以指导在美国标准血流速率下对 ESKD 患者进行 LIXELLE 的进一步研究。