PDF(Pubmed)
Abstract：
BACKGROUND: Hemodialyzers should efficiently eliminate small and middle molecular uremic toxins and possess exceptional hemocompatibility to improve well-being of patients with end-stage kidney disease. However, performance and hemocompatibility get compromised during treatment due to adsorption of plasma proteins to the dialyzer membrane. Increased membrane hydrophilicity reduces protein adsorption to the membrane and was implemented in the novel FX CorAL dialyzer. The present randomized controlled trial compares performance and hemocompatibility profiles of the FX CorAL dialyzer to other commonly used dialyzers applied in hemodiafiltration treatments.
METHODS: This prospective, open, controlled, multicentric, interventional, crossover study randomized stable patients on post-dilution online hemodiafiltration (HDF) to FX CorAL 600, FX CorDiax 600 (both Fresenius Medical Care) and xevonta Hi 15 (B. Braun) each for 4 weeks. Primary outcome was β2-microglobulin removal rate (β2-m RR). Non-inferiority and superiority of FX CorAL versus comparators were tested. Secondary endpoints were RR and/or clearance of small and middle molecules, and intra- and interdialytic profiles of hemocompatibility markers, with regards to complement activation, cell activation/inflammation, platelet activation and oxidative stress. Further endpoints were patient reported outcomes (PROs) and clinical safety.
RESULTS: 82 patients were included and 76 analyzed as intention-to-treat (ITT) population. FX CorAL showed the highest β2-m RR (76.28%), followed by FX CorDiax (75.69%) and xevonta (74.48%). Non-inferiority to both comparators and superiority to xevonta were statistically significant. Secondary endpoints related to middle molecules corroborated these results; performance for small molecules was comparable between dialyzers. Regarding intradialytic hemocompatibility, FX CorAL showed lower complement, white blood cell, and platelet activation. There were no differences in interdialytic hemocompatibility, PROs, or clinical safety.
CONCLUSIONS: The novel FX CorAL with increased membrane hydrophilicity showed strong performance and a favorable hemocompatibility profile as compared to other commonly used dialyzers in clinical practice. Further long-term investigations should examine whether the benefits of FX CorAL will translate into improved cardiovascular and mortality endpoints.
BACKGROUND: eMPORA III registration on 19/01/2021 at ClinicalTrials.gov (NCT04714281).
METHODS: This prospective, open, controlled, multicentric, interventional, crossover study randomized stable patients on post-dilution online hemodiafiltration (HDF) to FX CorAL 600, FX CorDiax 600 (both Fresenius Medical Care) and xevonta Hi 15 (B. Braun) each for 4 weeks. Primary outcome was β2-microglobulin removal rate (β2-m RR). Non-inferiority and superiority of FX CorAL versus comparators were tested. Secondary endpoints were RR and/or clearance of small and middle molecules, and intra- and interdialytic profiles of hemocompatibility markers, with regards to complement activation, cell activation/inflammation, platelet activation and oxidative stress. Further endpoints were patient reported outcomes (PROs) and clinical safety.
RESULTS: 82 patients were included and 76 analyzed as intention-to-treat (ITT) population. FX CorAL showed the highest β2-m RR (76.28%), followed by FX CorDiax (75.69%) and xevonta (74.48%). Non-inferiority to both comparators and superiority to xevonta were statistically significant. Secondary endpoints related to middle molecules corroborated these results; performance for small molecules was comparable between dialyzers. Regarding intradialytic hemocompatibility, FX CorAL showed lower complement, white blood cell, and platelet activation. There were no differences in interdialytic hemocompatibility, PROs, or clinical safety.
CONCLUSIONS: The novel FX CorAL with increased membrane hydrophilicity showed strong performance and a favorable hemocompatibility profile as compared to other commonly used dialyzers in clinical practice. Further long-term investigations should examine whether the benefits of FX CorAL will translate into improved cardiovascular and mortality endpoints.
BACKGROUND: eMPORA III registration on 19/01/2021 at ClinicalTrials.gov (NCT04714281).
摘要：
背景：血液透析器应有效消除小分子和中分子尿毒症毒素，并具有特殊的血液相容性，以改善终末期肾病患者的健康状况。然而,由于血浆蛋白吸附到透析器膜，在治疗期间性能和血液相容性受到损害。增加的膜亲水性减少了蛋白质对膜的吸附，并在新型FXCorAL透析器中实施。本随机对照试验比较了FXCorAL透析器与血液透析滤过治疗中使用的其他常用透析器的性能和血液相容性。
方法：这种前瞻性，打开,控制,多中心,介入,交叉研究将稀释后在线血液透析滤过（HDF）的稳定患者随机分为FXCorAL600，FXCorDiax600（包括FreseniusMedicalCare）和xevontaHi15（B.布劳恩)每人4周。主要结果是β2-微球蛋白去除率（β2-mRR）。检验了FXCorAL与比较者的非劣效性和优越性。次要终点是RR和/或小分子和中分子的清除，以及血液相容性标志物的透析内和透析间概况，关于补体激活，细胞活化/炎症，血小板活化和氧化应激。进一步的终点是患者报告的结果（PRO）和临床安全性。
结果：82例患者被纳入，76例作为意向治疗（ITT）人群进行分析。FX珊瑚显示出最高的β2-mRR(76.28%)，其次是FXCorDiax（75.69%）和xevonta（74.48%）。对两个比较者的非劣效性和对xevonta的优越性具有统计学意义。与中间分子相关的次要终点证实了这些结果；透析器之间小分子的性能相当。关于血液透析相容性，FX珊瑚显示补体较低，白细胞,和血小板活化。透析间血液相容性没有差异，PROs,或临床安全。
结论：与临床实践中其他常用的透析器相比，具有增加的膜亲水性的新型FXCorAL显示出强大的性能和良好的血液相容性特征。进一步的长期调查应检查FXCorAL的益处是否会转化为改善的心血管和死亡率终点。
背景：eMPORAIII于2021年1月19日在ClinicalTrials.gov（NCT04714281）注册。
方法：这种前瞻性，打开,控制,多中心,介入,交叉研究将稀释后在线血液透析滤过（HDF）的稳定患者随机分为FXCorAL600，FXCorDiax600（包括FreseniusMedicalCare）和xevontaHi15（B.布劳恩)每人4周。主要结果是β2-微球蛋白去除率（β2-mRR）。检验了FXCorAL与比较者的非劣效性和优越性。次要终点是RR和/或小分子和中分子的清除，以及血液相容性标志物的透析内和透析间概况，关于补体激活，细胞活化/炎症，血小板活化和氧化应激。进一步的终点是患者报告的结果（PRO）和临床安全性。
结果：82例患者被纳入，76例作为意向治疗（ITT）人群进行分析。FX珊瑚显示出最高的β2-mRR(76.28%)，其次是FXCorDiax（75.69%）和xevonta（74.48%）。对两个比较者的非劣效性和对xevonta的优越性具有统计学意义。与中间分子相关的次要终点证实了这些结果；透析器之间小分子的性能相当。关于血液透析相容性，FX珊瑚显示补体较低，白细胞,和血小板活化。透析间血液相容性没有差异，PROs,或临床安全。
结论：与临床实践中其他常用的透析器相比，具有增加的膜亲水性的新型FXCorAL显示出强大的性能和良好的血液相容性特征。进一步的长期调查应检查FXCorAL的益处是否会转化为改善的心血管和死亡率终点。
背景：eMPORAIII于2021年1月19日在ClinicalTrials.gov（NCT04714281）注册。
