TY - JOUR
T1 - A trial evaluating mid cut-off value membrane clearance of albumin and light chains in hemodialysis patients
T2 - A safety device study
AU - Krishnasamy, Rathika
AU - Hawley, Carmel M.
AU - Jardine, Meg J.
AU - Roberts, Matthew A.
AU - Cho, Yeoungjee
AU - Wong, Muhgeot
AU - Heath, Anne
AU - Nelson, Craig L.
AU - Sen, Shaundeep
AU - Mount, Peter F.
AU - Pascoe, Elaine M.
AU - Vergara, Liza A.
AU - Paul-Brent, Peta Anne
AU - Toussaint, Nigel D.
AU - Johnson, David W.
AU - Hutchison, Colin A.
N1 - Funding Information:
A comprehensive description of REMOVAL-HD study design has been published elsewhere [8]. REMOVAL-HD was an investigator-initiated, open-label, non-randomized, device study conducted in 9 in-center HD units in Australia and New Zealand. Recruitment commenced in January 2017 and the last participant follow-up occurred in April 2018. The study was coordinated and supported by the Australasian Kidney Trials Network (AKTN). A trial steering committee consisting of clinicians and statisticians were solely responsible for the trial design, conduct, data analysis, and manuscript preparation. The trial steering committee was also responsible for the scientific integrity of the trial by overseeing the monitoring of albumin levels, serious adverse events (SAE) and operational data. The study protocol was reviewed and critiqued by the AKTN Scientific Committee. Ethical approval was obtained from Institutional Ethics Committees 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. This study is registered with the Australian and New Zealand Clinical Trials Registry (ANZCTRN 12616000804482).
Publisher Copyright:
© 2020 S. Karger AG. All rights reserved.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - Background: A new class of dialysis membrane, the mid cut-off (MCO) dialyzer, has been developed to improve the clearance of uremic toxins in hemodialysis (HD). The a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HemoDialysis patients (REMOVAL-HD) study aimed to determine if regular use of MCO dialyzer was safe and specifically did not result in a significant loss of albumin. Methods: This investigator initiated, crossover, longitudinal, device study was conducted across 9 centers in Australia and New Zealand (n = 89). Participants had a 4-week wash-in with high-flux HD, followed by 24-week intervention with MCO HD and a subsequent 4-week wash-out with high-flux HD. The primary outcome was change in serum albumin between weeks 4 and 28. Secondary outcomes included trends in serum albumin, changes in kappa-and lambda-free light chains (FLC), 6-min walk test (6MWT), malnutrition inflammation score (MIS), restless legs score and quality of life. Results: Participants had a mean age of 66 ± 14 years, 62% were men, 45% were anuric, and 51% had-diabetes. There was no reduction in serum albumin following treatment with MCO HD (mean reduction-0.7 g/L, 95% CI-1.5 to 0.1). A sustained, unexplained reduction in serum albumin (>25%) was not observed in any participant. A reduction in FLC was observed 2 weeks into MCO HD (lambda-FLC: Δ-9.1 mg/L, 95% CI-14.4 to-3.7; kappa-FLC: Δ-5.7 mg/L, 95% CI-9.8 to-1.6) and was sustained for the rest of the study intervention. Both FLC increased after the cessation of MCO use. There was no improvement in restless legs symptoms, quality of life, 6MWT or MIS scores. Conclusions: Regular HD using the MCO dialyzer did not result in a significant fall in serum albumin. There were no effects on quality of life, functional status or nutrition. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482.
AB - Background: A new class of dialysis membrane, the mid cut-off (MCO) dialyzer, has been developed to improve the clearance of uremic toxins in hemodialysis (HD). The a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HemoDialysis patients (REMOVAL-HD) study aimed to determine if regular use of MCO dialyzer was safe and specifically did not result in a significant loss of albumin. Methods: This investigator initiated, crossover, longitudinal, device study was conducted across 9 centers in Australia and New Zealand (n = 89). Participants had a 4-week wash-in with high-flux HD, followed by 24-week intervention with MCO HD and a subsequent 4-week wash-out with high-flux HD. The primary outcome was change in serum albumin between weeks 4 and 28. Secondary outcomes included trends in serum albumin, changes in kappa-and lambda-free light chains (FLC), 6-min walk test (6MWT), malnutrition inflammation score (MIS), restless legs score and quality of life. Results: Participants had a mean age of 66 ± 14 years, 62% were men, 45% were anuric, and 51% had-diabetes. There was no reduction in serum albumin following treatment with MCO HD (mean reduction-0.7 g/L, 95% CI-1.5 to 0.1). A sustained, unexplained reduction in serum albumin (>25%) was not observed in any participant. A reduction in FLC was observed 2 weeks into MCO HD (lambda-FLC: Δ-9.1 mg/L, 95% CI-14.4 to-3.7; kappa-FLC: Δ-5.7 mg/L, 95% CI-9.8 to-1.6) and was sustained for the rest of the study intervention. Both FLC increased after the cessation of MCO use. There was no improvement in restless legs symptoms, quality of life, 6MWT or MIS scores. Conclusions: Regular HD using the MCO dialyzer did not result in a significant fall in serum albumin. There were no effects on quality of life, functional status or nutrition. Trial Registration: Australian New Zealand Clinical Trials Registry Number (ANZCTRN) 12616000804482.
UR - http://www.scopus.com/inward/record.url?scp=85078983915&partnerID=8YFLogxK
U2 - 10.1159/000505567
DO - 10.1159/000505567
M3 - Article
C2 - 31968346
AN - SCOPUS:85078983915
SN - 0253-5068
VL - 49
SP - 468
EP - 478
JO - Blood Purification
JF - Blood Purification
IS - 4
ER -
