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

R Krishnasamy, C M Hawley, M J Jardine, M A Roberts, Y J Cho, M G Wong, A Heath, C L Nelson, S Sen, P F Mount, E M Pascoe, D Darssan, L A Vergara, P A Paul-Brent, N D Toussaint, D W Johnson, C A Hutchison, R Krishnasamy, C M Hawley, M J Jardine, M A Roberts, Y J Cho, M G Wong, A Heath, C L Nelson, S Sen, P F Mount, E M Pascoe, D Darssan, L A Vergara, P A Paul-Brent, N D Toussaint, D W Johnson, C A Hutchison

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.

Keywords: Albumin; Dialyser; Efficacy; Free light chains; Haemodialysis; Mid cut-off membrane; Safety.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been obtained from Institutional Ethics Committees (IEC) for participating sites [Melbourne Health HREC (reference number: HREC/16/MH/228) for Australian sites and Northern B Health and Disability Ethics Committee (reference number: 16/NTB/126) for NZ sites] and local governance approval gained for each site. Informed signed consent was obtained from all participants.

Consent for publication

Not applicable.

Competing interests

This study is funded by Baxter Investigator Initiated Research (IIR) Grant.

Each authors declaration:

CAH has received research funding from Baxter and has participated on dialysis advisory boards for Baxter. MJJ is supported by a co-funded National Health and Medical Research Council Career Development Fellowship and National Heart Foundation Future Leader Fellowship; is responsible for research projects that have received unrestricted funding from Gambro, Baxter, CSL, Amgen, Eli Lilly, and Merck; has served on advisory boards and/or spoken at scientific meetings sponsored by Boehringer Ingelheim, Baxter, Amgen and Roche; and directs honoraria to clinical research programs.

DWJ has received research funds, consultancy fees, speaker’s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care. He is currently supported by a National Health and Medical Research Council Practitioner Fellowship. CMH has received research funds from Baxter Healthcare and Fresenius Medical Care. MGW is supported by Diabetes Australian Research Trust and has received fees for scientific lectures from AstraZeneca, Amgen and Baxter. YC has received research funds from Baxter Healthcare and Fresenius Medical Care. She is currently supported by a National Health and Medical Research Council Early Career Fellowship. RK has received speaker’s honoraria from Shire.

Publisher’s Note

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Figures

Fig. 1
Fig. 1
Overall study timeline
Fig. 2
Fig. 2
Timing of visits and changes in study treatment

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