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
In: BMC Nephrology, Jg. 19 (2018), Heft 1, S. 1-8
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Abstract Background 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. Methods 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. Discussion 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. Trial registration Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482. Date of registration - 21/06/2016.
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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
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Autor/in / Beteiligte Person: | 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, P. F. ; Pascoe, E. M. ; Darssan, D. ; Vergara, L. A. ; Paul-Brent, P. A. ; Toussaint, N. D. ; Johnson, D. W. ; Hutchison, C. A. |
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Zeitschrift: | BMC Nephrology, Jg. 19 (2018), Heft 1, S. 1-8 |
Veröffentlichung: | BMC, 2018 |
Medientyp: | academicJournal |
ISSN: | 1471-2369 (print) |
DOI: | 10.1186/s12882-018-0883-8 |
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