Effect of Hemodiafiltration on the Progression of Neuropathy with Kidney Failure

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 and measurements: FINESSE was an open-label, blinded endpoint 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 4 study centers. The primary outcome was the mean change in the yearly modified Total Neuropathy Score (mTNS) 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 (mTNS greater than or equal to 2) and 38 (31%) had moderate to severe neuropathy (mTNS 9-28). Convection volume in the hemodiafiltration arm was median (interquartile range) 24.7 (22.4-26.5)L. The mean mTNS (SE) 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 (HR 1.24 (0.61 to 2.51), log rank p=0.55) or any of the pre-specified 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 (0.83-1.32) 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. Trial registration: ACTRN12609000615280