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Kidney Week

Abstract: FR-PO0505

Real-World Clinical Performance of FX CorAL Dialyzer in Patients on Hemodialysis

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Zhou, Meijiao, Renal Research Institute, LLC, Waltham, Massachusetts, United States
  • Ficociello, Linda, Renal Research Institute, LLC, Waltham, Massachusetts, United States
  • Lasky, Rachel A., Renal Research Institute, LLC, Waltham, Massachusetts, United States
  • Anger, Michael S., Fresenius Medical Care, Waltham, Massachusetts, United States
Background

FX CorAL® dialyzers (FXC) are 510(k) cleared, high-flux, single-use, inline steam-sterilized dialyzers. Clinical studies have demonstrated strong clinical performance and favorable hemocompatibility (Götz Ehlerding et al., Kidney360, 2(6), pp.937-947.). This retrospective study assesses changes in dialysis adequacy and inflammatory markers before and after the implementation of FXC among hemodialysis (HD) patients.

Methods

Adult, in-center Fresenius Kidney Care (FKC) HD patients who switched from Optiflux dialyzers to FXC as part of routine care for 2+ weeks were included. Eligible patients maintained the same vascular access and dialysis prescription (treatment time, needle size, dialysate and blood flow rate) before and after the switch. Patients with a history of liver disease, cancer, HIV, or drug use were excluded. Parameters were averaged over baseline (BL; 4 weeks before FXC) and follow up (FUP; up to 4 weeks after FXC).

Results

Patients (n=173) had a mean age of 63 years and HD vintage of 49 months; 35% were female, and 17% were African American. Common comorbidities included hypertension (86%), diabetes (51%), congestive heart failure (40%) and cardiovascular disease (13%).
Following the switch to FXC, mean Kt/V remained stable. However, 8% more patients reached spKt/V≥1.4 (p=0.02). Trends in WBC and % with NLR<3.5 were not statistically significant. Treatment parameters remained consistent between BL to FUP.

Conclusion

Over a 2-4 week FUP, HD patients with consistent dialysis prescriptions switching to FXC maintained mean dialysis adequacy and relevant labs. A trend toward a higher % achieving spKt/V≥ 1.4 was observed. These findings warrant confirmation in a larger patient population and over a longer FUP.

Funding

  • Commercial Support – Fresenius Medical Care

Digital Object Identifier (DOI)