Effect of Hemodiafiltration on the Progression of Neuropathy with Kidney Failure: A Randomized Controlled Trial.

Kang, A; Arnold, R; Gallagher, M; Snelling, P; Green, J; Fernando, M; Kiernan, MC; Hand, S; Grimley, K; Burman, J; Heath, A; Rogers, K; Bhattacharya, A; Smyth, B; Bradbury, T; Hawley, C; Perkovic, V; Krishnan, AV; Jardine, MJ; FINESSE Steering Committee,

Effect of Hemodiafiltration on the Progression of Neuropathy with Kidney Failure: A Randomized Controlled Trial.

Kang, A Arnold, R Gallagher, M Snelling, P Green, J Fernando, M Kiernan, MC Hand, S Grimley, K Burman, J Heath, A Rogers, K

Bhattacharya, A Smyth, B Bradbury, T Hawley, C Perkovic, V Krishnan, AV Jardine, MJ FINESSE Steering Committee,

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Publisher:: American Society of Nephrology (ASN)
Publication Type:: Journal Article
Citation:: Clin J Am Soc Nephrol, 2021, 16, (9), pp. 1365-1375
Issue Date:: 2021-09

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Field	Value	Language
dc.contributor.author	Kang, A
dc.contributor.author	Arnold, R
dc.contributor.author	Gallagher, M
dc.contributor.author	Snelling, P
dc.contributor.author	Green, J
dc.contributor.author	Fernando, M
dc.contributor.author	Kiernan, MC
dc.contributor.author	Hand, S
dc.contributor.author	Grimley, K
dc.contributor.author	Burman, J
dc.contributor.author	Heath, A
dc.contributor.author	Rogers, K https://orcid.org/0000-0001-5497-4298
dc.contributor.author	Bhattacharya, A
dc.contributor.author	Smyth, B
dc.contributor.author	Bradbury, T
dc.contributor.author	Hawley, C
dc.contributor.author	Perkovic, V
dc.contributor.author	Krishnan, AV
dc.contributor.author	Jardine, MJ
dc.contributor.author	FINESSE Steering Committee,
dc.date.accessioned	2022-06-14T23:03:45Z
dc.date.available	2021-06-23
dc.date.available	2022-06-14T23:03:45Z
dc.date.issued	2021-09
dc.identifier.citation	Clin J Am Soc Nephrol, 2021, 16, (9), pp. 1365-1375
dc.identifier.issn	1555-9041
dc.identifier.issn	1555-905X
dc.identifier.uri	http://hdl.handle.net/10453/158170
dc.description.abstract	BACKGROUND AND OBJECTIVES: Neuropathy is a common complication of kidney disease that lacks proven disease-modifying treatments. Hemodiafiltration improves clearance of uremic toxins and is associated with better nerve function than hemodialysis. We aimed to determine whether hemodiafiltration reduces the progression of neuropathy in people receiving hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The Filtration in the Neuropathy of End-Stage Kidney Disease Symptom Evolution (FINESSE) study was an open-label, blinded end point assessment, controlled trial that randomized maintenance hemodialysis recipients to hemodiafiltration or high-flux hemodialysis for 48 months or until death or cessation of dialysis at four study centers. The primary outcome was the mean change in the yearly modified total neuropathy score from baseline, with time points weighted equally. RESULTS: A total of 124 participants were randomized and followed for a mean of 41 months. At baseline, neuropathy was present in 91 (73%) participants (modified total neuropathy score greater than or equal to two), and 38 (31%) had moderate to severe neuropathy (modified total neuropathy score 9-28). Convection volume in the hemodiafiltration arm was a median of 24.7 (interquartile range, 22.4-26.5) L. The mean modified total neuropathy score (SEM) worsened by 1.7 (0.4)/28 and 1.2 (0.4)/28 in the hemodiafiltration and hemodialysis groups, respectively, with a mean difference of 0.5 (95% confidence interval, -0.7 to 1.7; P=0.37). There was no difference in survival (hazard ratio, 1.24; 95% confidence interval, 0.61 to 2.51; log rank P=0.55) or any of the prespecified adverse events. There was no difference between groups in the number of participants who suffered an adverse event adjusted by follow-up time (relative risk, 1.05; 95% confidence interval, 0.83 to 1.32; P=0.68). CONCLUSIONS: Neuropathy is still a common complication of kidney disease without disease-altering therapy. Hemodiafiltration did not affect neuropathy progression compared with hemodialysis. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Filtration in the Neuropathy of End-Stage Kidney Disease Symptom Evolution (FINESSE), ACTRN12609000615280.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	American Society of Nephrology (ASN)
dc.relation.ispartof	Clin J Am Soc Nephrol
dc.relation.isbasedon	10.2215/CJN.17151120
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1103 Clinical Sciences
dc.subject.classification	Urology & Nephrology
dc.subject.mesh	Aged
dc.subject.mesh	Aged, 80 and over
dc.subject.mesh	Disease Progression
dc.subject.mesh	Female
dc.subject.mesh	Hemodiafiltration
dc.subject.mesh	Humans
dc.subject.mesh	Kidney Failure, Chronic
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Peripheral Nervous System Diseases
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Renal Dialysis
dc.subject.mesh	Humans
dc.subject.mesh	Peripheral Nervous System Diseases
dc.subject.mesh	Kidney Failure, Chronic
dc.subject.mesh	Disease Progression
dc.subject.mesh	Renal Dialysis
dc.subject.mesh	Hemodiafiltration
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Aged
dc.subject.mesh	Aged, 80 and over
dc.subject.mesh	Middle Aged
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.title	Effect of Hemodiafiltration on the Progression of Neuropathy with Kidney Failure: A Randomized Controlled Trial.
dc.type	Journal Article
utslib.citation.volume	16
utslib.location.activity	United States
utslib.for	1103 Clinical Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
utslib.copyright.status	closed_access	*
dc.date.updated	2022-06-14T23:03:43Z
pubs.issue	9
pubs.publication-status	Published
pubs.volume	16
utslib.citation.issue	9

Abstract:

BACKGROUND AND OBJECTIVES: Neuropathy is a common complication of kidney disease that lacks proven disease-modifying treatments. Hemodiafiltration improves clearance of uremic toxins and is associated with better nerve function than hemodialysis. We aimed to determine whether hemodiafiltration reduces the progression of neuropathy in people receiving hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: The Filtration in the Neuropathy of End-Stage Kidney Disease Symptom Evolution (FINESSE) study was an open-label, blinded end point assessment, controlled trial that randomized maintenance hemodialysis recipients to hemodiafiltration or high-flux hemodialysis for 48 months or until death or cessation of dialysis at four study centers. The primary outcome was the mean change in the yearly modified total neuropathy score from baseline, with time points weighted equally. RESULTS: A total of 124 participants were randomized and followed for a mean of 41 months. At baseline, neuropathy was present in 91 (73%) participants (modified total neuropathy score greater than or equal to two), and 38 (31%) had moderate to severe neuropathy (modified total neuropathy score 9-28). Convection volume in the hemodiafiltration arm was a median of 24.7 (interquartile range, 22.4-26.5) L. The mean modified total neuropathy score (SEM) worsened by 1.7 (0.4)/28 and 1.2 (0.4)/28 in the hemodiafiltration and hemodialysis groups, respectively, with a mean difference of 0.5 (95% confidence interval, -0.7 to 1.7; P=0.37). There was no difference in survival (hazard ratio, 1.24; 95% confidence interval, 0.61 to 2.51; log rank P=0.55) or any of the prespecified adverse events. There was no difference between groups in the number of participants who suffered an adverse event adjusted by follow-up time (relative risk, 1.05; 95% confidence interval, 0.83 to 1.32; P=0.68). CONCLUSIONS: Neuropathy is still a common complication of kidney disease without disease-altering therapy. Hemodiafiltration did not affect neuropathy progression compared with hemodialysis. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Filtration in the Neuropathy of End-Stage Kidney Disease Symptom Evolution (FINESSE), ACTRN12609000615280.

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