Efficacy and safety of the Clearum dialyzer

A hallmark of chronic kidney disease is the retention of solutes that normally are eliminated by the kidneys. The current classification defines uremic toxins based on molecular weight and protein affinity. The retention of solutes is already detected in the early stages of the disease when patients are pauci-symptomatic or asymptomatic but the role of therapies to retard the loss of kidney function in patients with chronic kidney disease (e.g., modulators of the renin-angiotensin-aldosterone system, sodium-glucose cotransporter inhibitors) in reducing uremic toxins is poorly understood. Most of the research evaluating the impact of therapies to lower serum concentrations of those toxic compounds is carried out in patients with kidney failure already undergoing kidney replacement therapy. The removal of those molecules relies in physicochemical mass transfer phenomena, i.e., adsorption, diffusion, and convection. In the past 2 decades, the rise and broad adoption of blood purification strategies with enhanced convective properties, such as high-volume online hemodiafiltration and expanded hemodialysis, considerably amplified the ability to mechanically extract middle molecules (molecular weight >0.5 kDa) from the blood compartment. Nonetheless, the classification of uremic toxins has not evolved in parallel with dialysis advancements. Mounting evidence demonstrates the link between middle molecules with uremic symptoms, cardiovascular and mortality risks. An urgent need for updating the classification exists. Defining the causative relationship between specific solutes and specific clinical outcomes will promote the development of targeted therapies. In parallel, the inclusion of new pertinent dimensions to the classification like the influence of new dialysis membranes, sorbents, and intestinal chelators in the concentration of uremic toxins would improve the understanding of the pathogenesis of chronic kidney disease, setting the pace for future research in nephrology.

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“…Blood Purif DOI: 10.1159/000528983 than in HF which is to be replicated in fuanalysis of HDFit data [38,39,90].…”

Section: Post-dialysis Recovery Timementioning

confidence: 93%

Rationale for a New Classification of Solutes of Interest in Chronic Kidney Disease and Hemodialysis

et al. 2023

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“…The results of this study corroborate and extend those of Maduell, which assessed the dialyzer in short-term only; here, we support those by a novel in-vitro assay and add clinical medium-term data. 14…”

Section: Clearum Hs Hemodialyzer Sessionsmentioning

confidence: 99%

“…Fourteen (14) of the 20 patients (70%) previously used the high-flux Fresenius FX classix 100 dialyzer at baseline, while the remaining patients were using the FX classix 80 (n = 4) and FX classix 60 (n = 2), respectively. Average blood flow rates over the three months prior to the study ranged between 251-299 mL/min (n = 1), 300-349 mL/min (n = 9), and 350-400 mL/min (n = 10) in the enrolled patients.…”

Section: Demographic and Other Baseline Characteristicsmentioning

confidence: 99%

Safety and performance of the Clearum™ high flux hemodialyzer

Krüger,

Dellanna,

Kleophas

et al. 2023

Artificial Organs

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BackgroundClearum™ is a high flux steam sterilized dialyzer for patients with hemodialysis or hemodiafiltration. This study evaluated the safety and performance of the Clearum high flux steam sterilized hemodialyzer in the removal of small and middle‐sized toxins.MethodsA prospective, interventional, nonrandomized study enrolled twenty end‐stage renal disease patients undergoing hemodialysis. The Clearum high flux steam sterilized dialyzer was compared to Fresenius FX dialyzers for baseline comparison. The duration of the trial was 2 weeks for the FX dialyzer and 6 weeks with the Clearum high flux steam sterilized dialyzer. In vitro studies with dextrans of varying sizes were performed to compare the membrane characteristics and sieving coefficient curves for the two dialyzers.ResultsThe primary objective of a mean urea reduction ratio >65% was met, with no significant difference in mean urea reduction ratio between the Clearum high flux steam sterilized and Fresenius FX‐series of dialyzers (p = 0.86). No dialyzer‐related adverse events were reported in the study. β‐2‐microglobulin reduction with the Clearum high flux steam sterilized dialyzer was statistically higher than the FX‐series dialyzer (66.5% vs. 53.6%; p < 0.0001). Predialysis interleukin‐6 and C‐reactive protein concentrations, blood‐rest scores (residual blood after blood restitution), and thrombin‐anti‐thrombin values were comparable. Albumin remained stable during the 6 weeks of Clearum high flux steam sterilized dialyzer use, with no appreciable differences compared to the Fresenius FX‐series.ConclusionThe Clearum high flux steam sterilized dialyzer showed good mid‐term effectivity for small and middle molecule removal with no reported dialyzer‐related adverse events.

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“…31,32 When post-HDF is prescribed, the dialyzer membrane should also be chosen with caution, because the performance of the different dialyzers varies, even when other dialysis parameters remain unchanged. 9,22,33,34 Studies comparing HDF with polyamide 25,26,35 and first-generation helixone 28 filters versus HDx obtained slightly inferior results compared with last-generation polysulfone filters. 8,9,22 The influence of the amount of convective volume in HDF seems to be decisive in achieving or enhancing the performance of HDx.…”

Section: Efficacy Comparison Of Hdf Versus Hdxmentioning

confidence: 99%

“…Post‐dilution online hemodiafiltration (post‐HDF) has progressively evolved and can be considered a safe, fully consolidated treatment with multiple clinical advantages 10 . The ESHOL study reported longer survival in patients receiving post‐HDF, 11 and post hoc analysis of three randomized clinical trials with mortality as the primary endpoint showed an association between convective volume and survival 11–13 . In this regard, obtaining a replacement volume greater than 21 L per session has been recommended to achieve this survival benefit 14 …”

Section: Introductionmentioning

confidence: 99%

Hemodiafiltration (HDF) versus expanded hemodialysis (HDx)

Maduell

Broseta

2022

Seminars in Dialysis

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Medium cutoff (MCO) membranes have resulted in a novel dialyzer class designed to improve membrane permeability and have been postulated as an alternative to online hemodiafiltration since MCO membranes may achieve similar solute clearances.These membranes have been incorporated into clinical practice, and the term expanded HD (HDx) has been proposed to differentiate from high-flux hemodialysis.Efficacy, safety, and quality of life comparison of HDF versus HDx have been reviewed in this article.

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Efficacy and safety of the Clearum dialyzer

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 7 publications

References 21 publications

Rationale for a New Classification of Solutes of Interest in Chronic Kidney Disease and Hemodialysis

Rationale for a New Classification of Solutes of Interest in Chronic Kidney Disease and Hemodialysis

Safety and performance of the Clearum™ high flux hemodialyzer

Hemodiafiltration (HDF) versus expanded hemodialysis (HDx)

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