Abstract

Abstract Background and Aims HDx is a dialysis therapy that uses dialyzers with newly designed medium cut-off membranes (MCOs), which show a greater capacity for purification of middle molecules than conventional dialyzers and requires less technical resources than OL-HDF. However, it is not well known if HDx has comparable clinical results with OL-HDF. Therefore, the aim of this study was to evaluate the clinical differences between patients dialyzed with HDx and OL-HDF. Method A 24-week prospective study that included 43 patients between 18 and 80 years old, in OL-HDF at least 3 months before the start of the study, stratified by residual function; and randomized for HDx or HDF-OL therapy. Twenty-one patients assigned to HDx used the Theranova® 500 dialyzer with MCO membrane; and 22 patients with HDF-OL with Polyflux® 170H dialyzer. Variables related to dialysis were analyzed: blood flow rate (Qb), ultrafiltration volume (VUF), dialysis time, Kt/V, and complications; anemia [Hemoglobin (Hb), transferrin saturation (TSAT), Ferritin, erythropoietin stimulating agent (ESA) dosage (IU/week), erythropoietin resistance index (ERI), iron dose]; the bone mineral metabolism [calcium (Ca), phosphorus (Pi), product CaxPi, Paratohormone (PTH), fibroblast growth factor 23 (FGF-23)]; and healthcare resource utilization (hospitalization, cardiovascular events, infectious events and death). Results The substitution volume in the OL-HDF group was 24.4±3.2 liters. No significant differences were found in time of treatment, QB, residual diuresis or VUF. The Kt/V was similar in both groups HDx: 1.8±0.26; OL-HDF: 1.8±0.28. No significant differences in the number of adverse events during hemodialysis between the two groups. No differences in the levels of P, Ca, PTH between both groups. However, there were differences in FGF-23 at week 12 compared to baseline (HDx: -188±1351 pg/mL; OL-HDF: +218±1293 pg/mL, p=0.48). The iron dose showed no significant differences between both groups. The use of ESA was lower in the HDx group at the end of the study (HDx: 5605±7115 IU/Week; OL-HDF: 7667±5867 IU/Week), maintaining hemoglobin values stable throughout the study in both treatment groups (HDx: 11.2±1; OL-HDF: 11.7±0.8 g/dl at 24-week). Serum TSAT was comparable between the groups at all timepoints in the study. Serum ferritin levels were slightly higher in HDx group and showed an overall increase at Week 24. Both treatments were effective in maintaining pre-dialysis albumin levels. At 12 weeks (HDx: 0.06±0.47; OL-HDF: -0.01±0.26, p=0.889) and 24 weeks of treatment (HDx: -0.02±0.25; OL-HDF: - 0.02±0.34, p=0.5948) versus baseline. The assessment of rates of hospitalizations, cardiovascular events, infective episodes and death showed no substantial differences between both groups. Conclusion In our experience, HDx with Theranova® 500 is a safe and effective hemodialysis technique. A short-term HDx therapy decreases FGF23 levels and the needs of EPO compared to OL-HDF. Both techniques are similar in the other parameters analysed.

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