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Title: Design and methods of the REMOVAL-HD study: a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients.
Austin Authors: Krishnasamy, R;Hawley, C M;Jardine, M J;Roberts, M A;Cho, Y J;Wong, M G;Heath, A;Nelson, C L;Sen, S;Mount, Peter F ;Pascoe, E M;Darssan, D;Vergara, L A;Paul-Brent, P A;Toussaint, N D;Johnson, D W;Hutchison, C A
Affiliation: Department of Nephrology, Sunshine Coast University Hospital, Birtinya, QLD, Australia
Centre for Kidney Disease Research, The University of Queensland, Brisbane, Australia
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia
The George Institute for Global Health, UNSW, Sydney, Australia
San Renal Dialysis Unit, Sydney Adventist Hospital, Sydney, Australia
Department of Nephrology, Concord Repatriation and General Hospital, Sydney, Australia
Eastern Health Clinical School, Monash University, Melbourne, Australia
Department of Nephrology, Western Health, Melbourne, Australia
Department of Medicine, Western Health, University of Melbourne, Melbourne, Australia
Western Health Chronic Disease Alliance, Western Centre for Health Research and Education, Western Health, St Albans, Australia
Department of Nephrology, Austin Health, Heidelberg, Victoria, Australia
Department of Nephrology, The Royal Melbourne Hospital, Parkville, Australia
Department of Medicine, Hawke's Bay District Health Board, Hawke's Bay Hospital, Omahu Rd, Hastings, Hawkes Bay, New Zealand
Issue Date: 17-Apr-2018 2018-04-17
Publication information: BMC nephrology 2018; 19(1): 89
Abstract: Removal of uraemic toxins is inadequate using current dialysis strategies. A new class of dialysis membranes have been developed that allow clearance of larger middle molecules. The REMOVAL-HD study (a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients) will address safety, efficacy and the impact on patient-centred outcomes with the use of a mid cut-off (MCO) dialyser in a chronic haemodialysis (HD) population. REMOVAL-HD is an open label, prospective, non-randomised, single-arm, multi-centre device study in 85 chronic HD participants. All visits will be conducted during regular HD sessions and participants will undergo a 1 month wash-in period using a standardised high flux dialyser, 6 months of intervention with a MCO dialyser and 1 month of wash-out using a high flux dialyser. The primary endpoint is change in pre-dialysis concentrations of serum albumin, with secondary endpoints including the efficacy of clearance of free light chains and β-2 microglobulin, and patient-centred outcomes including quality of life, symptom burden, functional status, nutritional status, hospitalisation and death. MCO dialysers are a novel form of HD membrane. The REMOVAL-HD study is a pivotal study designed to monitor the immediate and medium-term effects following exposure to this dialyser. Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482 . Date of registration - 21/06/2016.
DOI: 10.1186/s12882-018-0883-8
ORCID: 0000-0001-6974-7880
PubMed URL: 29665795
Type: Journal Article
Subjects: Albumin
Free light chains
Mid cut-off membrane
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