Comparison of hemodialysis with medium 
cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules

Belmouaz, Mohamed; Diolez, Jeremy; Bauwens, Marc; Duthe, Fabien; Écotière, Laure; Desport, Éstelle; Bridoux, Frank

doi:10.5414/cn109133

Cited by 36 publications

(51 citation statements)

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“…Hemodialysis with the MCO membranes is associated with albumin loss of approximately 3 g per session (6). In an initial assessment of MCO dialyzers, Belmouaz et al (46) monitored ten patients converted from online HDF to MCO dialysis and did not identify a significant change in serum albumin concentrations, suggesting that this level of albumin loss is tolerable. The REMOVAL-HD Study in Australia and New Zealand is a single-arm, multicenter study designed to specifically address the safety of MCO dialysis (ANZCTRN 12616000804482).…”

Section: Clinical Evaluation Of Mco Dialyzersmentioning

confidence: 99%

Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules

Wolley

Jardine

Hutchison

2018

CJASN

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Dialysis technologies have continued to advance over recent decades; however, these advancements have not always been met with improved patient outcomes. In part, the high morbidity and mortality associated with dialysis have been attributed to a group of uremic toxins, which are described as "difficult to remove." With a new generation of hemodialysis membranes now making meaningful clearance of these molecules possible, it is an apt time to review the clinical relevance of these middle molecules. Our review describes the developments in membrane technology that enable the removal of large middle molecules (molecular mass >15 kD) that is limited with high-flux dialysis membranes. Of the known 58 middle molecules, a literature search identified 27 that have molecular mass >15 kD. This group contains cytokines, adipokines, hormones, and other proteins. These molecules are implicated in chronic inflammation, atherosclerosis, structural heart disease, and secondary immunodeficiency in the literature. Single-center safety and efficacy studies have identified that use of these membranes in maintenance dialysis populations is associated with limited loss of albumin and increased clearance of large middle molecules. Larger, robustly conducted, multicenter studies are now evaluating these findings. After completion of these safety and efficacy studies, the perceived clinical benefits of providing clearance of large middle molecules must be assessed in rigorously conducted, randomized clinical studies.

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Section: Clinical Evaluation Of Mco Dialyzersmentioning

confidence: 99%

Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules

Wolley

Jardine

Hutchison

2018

CJASN

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“…Existing data on the performance of medium cut-off dialyzers are on the basis of short-term, nonrandomized clinical trials (13)(14)(15)(16)(17)(18)(19). Accordingly, this randomized, controlled trial was conducted to evaluate the efficacy of expanded HD with the Theranova 400 membrane for larger middle molecule removal with acceptable serum albumin loss and safety profile over a 6-month period.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer

Weiner

Falzon

Skoufos

et al. 2020

CJASN

101

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Background and objectivesExpanded 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, & measurementsClinically 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.ResultsAmong 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.ConclusionsHemodialysis 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.Clinical Trial registry name and registration numberA 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.

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“…Medium cut-off (MCO) dialyzers can remove middle and large uremic toxins close to the molecular size of albumin (68,000 Da) [11][12][13][14]. MCO dialyzers have been introduced to the dialysis practice as they can perform hemodialysis as efficient as online HDF.…”

Section: Introductionmentioning

confidence: 99%

“…MCO dialyzers have been introduced to the dialysis practice as they can perform hemodialysis as efficient as online HDF. To test this hypothesis, studies were usually performed between hemodialysis with an MCO dialyzer and online HDF with a high-flux dialyzer [12][13][14][15][16][17]. Although global major renal replacement therapy modality is conventional hemodialysis using high-flux dialyzers, there are however relatively few studies comparing MCO and high-flux dialyzers in hemodialysis practice [11,16,18].…”

Section: Introductionmentioning

confidence: 99%

Comparison of Circulating Levels of Uremic Toxins in Hemodialysis Patients Treated with Medium Cut-Off Membranes and High-Flux Membranes: Theranova in Sisli Hamidiye Etfal (THE SHE) Randomized Control Study

et al. 2020

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Introduction: Removal of uremic toxins is a main objective of hemodialysis; however, whether high-flux and medium cutoff (MCO) membranes differ as regards removal of middle and large uremic toxins is not clear. Objective: To compare medium cutoff and high-flux dialyzers as regards their intra-and interdialysis effect on circulating levels of middle and large uremic toxins and serum albumin. Methods: Fiftytwo patients were randomized to have hemodialysis with either 3 months of high-flux dialyzer followed by 3 months of MCO or vice versa. Blood samples were taken before and after dialysis at the first and last sessions of each dialyzer for analyses of middle and large uremic toxins including inflammatory mediators and vascular endothelial growth factor (VEGF), and serum albumin. Results: Reduction rates were higher, and postdialysis levels of β-2 microglobulin, free kap-pa and lambda light chains, and myoglobulin were lower at the first and last sessions with MCO dialyzers compared to high-flux dialyzers (p < 0.05 for all). Last session predialysis levels of β-2 microglobulin, free kappa light chain, and free lambda light chain were lower than first session predialysis levels in MCO dialyzers as compared to high-flux dialyzers (p < 0.05 for all). Last session levels of interleukin-6, interleukin-10, interleukin-17, and interferon-gamma did not differ between dialyzers (p > 0.05 for all). VEGF level was lower in the MCO group compared to the high-flux group (p = 0.043). Last session level of serum albumin with MCO dialyzers was lower than that with high-flux dialyzers (3.62 [3.45-3.88] vs. 3.78 [3.58-4.02] g/L) (p = 0.04) and 6.7% lower (p < 0.001) than at the first session of MCO dialyzers. Conclusion: The decline in circulating levels of several middle and large uremic toxins including VEGF following hemodialysis was more pronounced when using MCO membranes as compared to high-flux membranes while their effect on inflammatory molecules was similar.

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Comparison of hemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules

Cited by 36 publications

References 0 publications

Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules

Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules

Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer

Comparison of Circulating Levels of Uremic Toxins in Hemodialysis Patients Treated with Medium Cut-Off Membranes and High-Flux Membranes: Theranova in Sisli Hamidiye Etfal (THE SHE) Randomized Control Study

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