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      A tRial Evaluating Mid Cut-Off Value Membrane Clearance of Albumin and Light Chains in HemoDialysis Patients: A Safety Device Study

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          Abstract

          Background: A new class of dialysis membrane, the mid cut-off (MCO) dialyzer, has been developed to improve the clearance of uremic toxins in hemodialysis (HD). The a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HemoDialysis patients (REMOVAL-HD) study aimed to determine if regular use of MCO dialyzer was safe and specifically did not result in a significant loss of albumin. Methods: This investigator initiated, crossover, longitudinal, device study was conducted across 9 centers in Australia and New Zealand ( n = 89). Participants had a 4-week wash-in with high-flux HD, followed by 24-week intervention with MCO HD and a subsequent 4-week wash-out with high-flux HD. The primary outcome was change in serum albumin between weeks 4 and 28. Secondary outcomes included trends in serum albumin, changes in kappa- and lambda-free light chains (FLC), 6-min walk test (6MWT), malnutrition inflammation score (MIS), restless legs score and quality of life. Results: Participants had a mean age of 66 ± 14 years, 62% were men, 45% were anuric, and 51% had ­diabetes. There was no reduction in serum albumin following treatment with MCO HD (mean reduction –0.7 g/L, 95% CI –1.5 to 0.1). A sustained, unexplained reduction in serum albumin (>25%) was not observed in any participant. A reduction in FLC was observed 2 weeks into MCO HD (lambda-FLC: Δ –9.1 mg/L, 95% CI –14.4 to –3.7; kappa-FLC: Δ –5.7 mg/L, 95% CI –9.8 to –1.6) and was sustained for the rest of the study intervention. Both FLC increased after the cessation of MCO use. There was no improvement in restless legs symptoms, quality of life, 6MWT or MIS scores. Conclusions: Regular HD using the MCO dialyzer did not result in a significant fall in serum albumin. There were no effects on quality of life, functional status or nutrition. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482.

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          Author and article information

          Journal
          BPU
          Blood Purif
          10.1159/issn.0253-5068
          Blood Purification
          S. Karger AG
          0253-5068
          1421-9735
          2020
          July 2020
          22 January 2020
          : 49
          : 4
          : 468-478
          Affiliations
          aDepartment of Nephrology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia
          bCenter for Kidney Disease Research, The University of Queensland, Brisbane, Queensland, Australia
          cAustralasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia
          dDepartment of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia
          eThe George Institute for Global Health, UNSW, Sydney, New South Wales, Australia
          fSan Renal Dialysis Unit, Sydney Adventist Hospital, Sydney, New South Wales, Australia
          gDepartment of Nephrology, Concord Repatriation and General Hospital, Sydney, New South Wales, Australia
          hEastern Health Clinical School, Monash University, Melbourne, Victoria, Australia
          iDepartment of Nephrology, Western Health, Melbourne, Victoria, Australia
          jDepartment of Medicine, Western Health, University of Melbourne, Melbourne, Victoria, Australia
          kWestern Health Chronic Disease Alliance, Western Centre for Health Research and Education, Western Health, St Albans, Victoria, Australia
          lDepartment of Nephrology, Austin Health, Melbourne, Victoria, Australia
          mDepartment of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia
          nDepartment of Medicine (RMH), The University of Melbourne, Parkville, Victoria, Australia
          oDepartment of Medicine, Hawke’s Bay Hospital, Hawkes Bay, New Zealand
          Author notes
          *Assoc. Prof. Rathika Krishnasamy, Centre for Kidney Disease Research, The University of Queensland, Translation Research Institute, Level 5, 37 Kent Street, Brisbane, QLD 4102 (Australia), E-Mail Rathika.Krishnasamy@health.qld.gov.au
          Article
          505567 Blood Purif 2020;49:468–478
          10.1159/000505567
          31968346
          © 2020 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          Page count
          Figures: 4, Tables: 4, Pages: 11
          Categories
          Hemodialysis – Research Article

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