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

• Published in: BMC nephrology 2018-04, Vol.19 (1), p.89-89, Article 89
• Main 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, P F, Pascoe, E M, Darssan, D, Vergara, L A, Paul-Brent, P A, Toussaint, N D, Johnson, D W, Hutchison, C A
• Format: Article
• Language: English
• Subjects: Adult; Albumin; beta 2-Microglobulin - blood; Care and treatment; Chronic kidney failure; Cost of Illness; Dialyser; Efficacy; Free light chains; Haemodialysis; Health aspects; Hemodialysis patients; Hospitalization; Humans; Immunoglobulin lambda-Chains - blood; Membranes, Artificial; Mid cut-off membrane; Nutritional Status; Patient Outcome Assessment; Prospective Studies; Quality of Life; Renal Dialysis - adverse effects; Renal Dialysis - instrumentation; Renal Dialysis - methods; Renal Insufficiency, Chronic - blood; Renal Insufficiency, Chronic - therapy; Research Design; Serum Albumin - metabolism; Study Protocol; Survival Analysis
• ISSN: 1471-2369; 1471-2369
• DOI: 10.1186/s12882-018-0883-8

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.