Tufts Medical Center, Medicine, Nephrology, Boston, Massachusetts.
Baxter Healthcare Corporation, Worldwide Medical, San Gwann, Malta.
Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1310-1319. doi: 10.2215/CJN.01210120. Epub 2020 Aug 25.
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.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: 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 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 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 <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 light chains, TNF, and 2-microglobulin (<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 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.
中分子量截留膜的扩展血液透析疗法可能会促进更大清除更大的中间分子，这些分子构成假定的尿毒症溶质，比传统的高通量透析更好。这项随机试验评估了中分子量截留透析器的血液透析治疗的疗效和安全性。
设计、地点、参与者和测量：接受维持性血液透析的临床稳定患者被随机分配接受中分子量截留透析器（Theranova 400）或高通量透析器（Elisio-17H）治疗，治疗时间为 24 周。主要安全性终点是治疗 24 周后透析前血清白蛋白水平。主要疗效终点是治疗 24 周时游离轻链的减少率。
在 172 名接受维持性血液透析的患者中，平均年龄为 59±13 岁，61%为男性，40%为黑人，平均透析时间为 5±4 年。在随机分配到每个透析器的 86 名患者中，每组有 65 名患者完成了试验。在治疗 4 周和 24 周时，Theranova 400 组游离轻链的清除率明显高于 Elisio-17H 组（分别为 39%和 33%，均<0.001）。在次要终点方面，Theranova 400 组在治疗 4 周和 24 周时，补体因子 D、游离轻链、TNF 和 2-微球蛋白的减少率显著更大（所有指标均<0.001），但 IL-6 除外。治疗 24 周后，两组的透析前血清白蛋白水平相似（Theranova 400 组为 4 g/dl，Elisio-17H 组为 4.1 g/dl），表明 Theranova 400 透析器在治疗 24 周后维持透析前血清白蛋白水平具有非劣效性。
与类似大小的高通量透析器相比，Theranova 400 透析器进行血液透析治疗可提供更大的中分子量物质清除效果，如游离轻链，同时维持血清白蛋白水平。
一项多中心、前瞻性、随机、对照、开放标签、平行研究，旨在评估终末期肾病（ESRD）患者中Theranova 400 透析器的安全性和疗效，NCT03257410。
