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Clin Kidney J.2025 Apr 11;18(5):sfaf106.doi:10.1093/ckj/sfaf106
Abstract
BACKGROUND: Medium cut-off hemodialysis (MCO-HD) improves removal of middle molecules (MM) uremic toxins. The effects of the novel super high-flux vitamin E-coated (SHFVE) dialyzer on MM removal and biocompatibility parameters including inflammation and oxidative stress remain to be investigated.
METHODS: This non-inferiority cross-over prospective randomized study included 36 patients randomly assigned to receive either 3 months of MCO-HD followed by 3 months of SHFVE-HD, or vice versa. The primary endpoint was beta2-microglobulin reduction ratio (RR) after 3 months. Secondary endpoints were other MM RR and biocompatibility parameters.
RESULTS: SHFVE-HD provided non-inferior beta2-microglobulin RR as compared with MCO-HD {74.2% [95% confidence interval (CI) 71; 77] vs 73.3% (95% CI 71; 76) with a difference of 0.9% (95% CI -1.9%; 3.6), respectively}, with similar mean RR of prolactin, alpha1-microglobulin, vascular endothelial growth factor, and kappa and lambda free light chains. SHFVE-HD induced lower mean myoglobin RR compared with MCO-HD (55.5 ± 7.3 vs 60.2 ± 6.6%, = 0.022). Myoglobin pre-dialysis levels were not significantly different [160 (118-199) vs 167 (167-240) µg/L, = .08].Median pre-dialysis levels of interleukin-6 [0.8 (0-4.4) vs 1.7 (0.2-7.2) pg/mL, = .032], asymmetric dimethylarginine (ADMA) [163 (122-260) vs 167 (133-270) ng/mL, = .01), mean pre-dialysis serum soluble tumor necrosis factor receptor 1 (sTNFR1) levels (12.7 ± 3.5 vs 13.6 ± 3.6 ng/mL, = .039) and mean post-dialysis oxidized low-density lipoprotein levels (54 ± 18 vs 63 ± 22 ng/mL, = .01) decreased significantly with SHFVE-HD. SHFVE-HD induced a significantly lower median relative variation in blood leucocyte count 15 min after dialysis initiation [-3.5 (-6.8 to 1.6) vs -6.2 (-12.9 to -1.5) %, = .009], encompassing both polymorphonuclear neutrophils and monocytes.
CONCLUSION: Compared with MCO-HD, SHFVE-HD appears to provide similar MM RR and may be associated with improved biocompatibility parameters.
TRIAL REGISTRATION CLINICALTRIALSGOV: NCT05610683. Data deposited at Centre de la recherche clinique CHU Poitiers.
