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
AuthorKrishnasamy, R; Hawley, CM; Jardine, MJ; Roberts, MA; Cho, YJ; Wong, MG; Heath, A; Nelson, CL; Sen, S; Mount, PF; ...
Source TitleBMC Nephrology
University of Melbourne Author/sMount, Peter
Document TypeJournal Article
CitationsKrishnasamy, 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. (2018). 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. BMC NEPHROLOGY, 19 (1), https://doi.org/10.1186/s12882-018-0883-8.
Access StatusOpen Access
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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