BMC Nephrology (Apr 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

  • 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

DOI
https://doi.org/10.1186/s12882-018-0883-8
Journal volume & issue
Vol. 19, no. 1
pp. 1 – 8

Abstract

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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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