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Abstract：
Expanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer.
Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free λ light chains at 24 weeks of treatment.
Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free λ light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both P<0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free κ light chains, TNFα, and β2-microglobulin (P<0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free λ light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.
A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.
Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free λ light chains at 24 weeks of treatment.
Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free λ light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both P<0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free κ light chains, TNFα, and β2-microglobulin (P<0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free λ light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.
A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.
摘要：
与常规的高通量透析相比，由中等截留膜实现的扩大血液透析疗法可以促进包含推定的尿毒症溶质的较大中间分子的更大清除。这项随机试验评估了使用中等截止透析器进行血液透析治疗的有效性和安全性。
临床稳定的维持性血液透析患者随机接受透析，在24周的治疗中使用中等截止透析器（Theranova400）或高通量透析器（Elisio-17H）进行透析。主要安全终点是治疗24周后的透析前血清白蛋白水平。主要功效终点是在治疗24周时游离λ轻链的减少比率。
在172名维持性血液透析患者中，平均年龄为59±13岁，61%是男性，40%是黑人,平均透析年份为5±4年。在随机分配给每个透析器的86名患者中，每组65人完成试验。在4周后(39%对20%)和24周后(33%对17%;均P<0.001),Theranova400组的游离λ轻链去除的减少比率显著高于Elisio-17H组。在次要终点中，Theranova400组在4周和24周时显示出明显更大的补体因子D的减少率，游离κ轻链，TNFα,和β2-微球蛋白（全部P<0.001），但不是IL-6.24周后，两组之间的透析前血清白蛋白水平相似（Theranova400为4g/dl，Elisio-17H为4.1g/dl），与Theranova400透析器在治疗24周后维持透析前血清白蛋白水平的非劣效性一致。
使用Theranova400透析器进行血液透析治疗可更好地去除较大的中间分子，以游离λ轻链为例，与类似尺寸的高通量透析器相比，同时维持血清白蛋白水平。
多中心，前瞻性,随机化,受控,打开标签,评估Theranova400透析器在终末期肾病（ESRD）患者中的安全性和有效性的平行研究，NCT03257410。
临床稳定的维持性血液透析患者随机接受透析，在24周的治疗中使用中等截止透析器（Theranova400）或高通量透析器（Elisio-17H）进行透析。主要安全终点是治疗24周后的透析前血清白蛋白水平。主要功效终点是在治疗24周时游离λ轻链的减少比率。
在172名维持性血液透析患者中，平均年龄为59±13岁，61%是男性，40%是黑人,平均透析年份为5±4年。在随机分配给每个透析器的86名患者中，每组65人完成试验。在4周后(39%对20%)和24周后(33%对17%;均P<0.001),Theranova400组的游离λ轻链去除的减少比率显著高于Elisio-17H组。在次要终点中，Theranova400组在4周和24周时显示出明显更大的补体因子D的减少率，游离κ轻链，TNFα,和β2-微球蛋白（全部P<0.001），但不是IL-6.24周后，两组之间的透析前血清白蛋白水平相似（Theranova400为4g/dl，Elisio-17H为4.1g/dl），与Theranova400透析器在治疗24周后维持透析前血清白蛋白水平的非劣效性一致。
使用Theranova400透析器进行血液透析治疗可更好地去除较大的中间分子，以游离λ轻链为例，与类似尺寸的高通量透析器相比，同时维持血清白蛋白水平。
多中心，前瞻性,随机化,受控,打开标签,评估Theranova400透析器在终末期肾病（ESRD）患者中的安全性和有效性的平行研究，NCT03257410。
