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.

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

doi:10.1186/s12882-018-0883-8

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.

Publication Date

2018-04-17

Author(s)

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

Subject

Albumin

Dialyser

Efficacy

Free light chains

Haemodialysis

Mid cut-off membrane

Safety

Type of document

Journal Article

OrcId

0000-0001-6974-7880

#PLACEHOLDER_PARENT_METADATA_VALUE#

DOI

10.1186/s12882-018-0883-8

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.

Link

link

Citation

BMC Nephrology 2018

Jornal Title

BMC Nephrology

Austin Health

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