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Abstract: PO1132

Clinical Safety of a New Hemodialyzer with the Surface Modifying Molecule EndexoTM

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Meyer, Jill M., California Institute of Renal Research, Chula Vista, California, United States
  • Steer, Dylan, California Institute of Renal Research, San Diego, California, United States
  • Weber, Lisa A., Research Management Inc./ Kansas Nephrology Research, Wichita, Kansas, United States
  • Thakuria, Mayuri, Fresenius Medical Care, North America, Waltham, Massachusetts, United States
  • Ho, Chiang-Hong, Fresenius Medical Care, North America, Waltham, Massachusetts, United States
  • Mullon, Claudy, Fresenius Medical Care, North America, Waltham, Massachusetts, United States
  • Kossmann, Robert J., Fresenius Medical Care, North America, Waltham, Massachusetts, United States
Background

The new Optiflux EnexaTM dialyzer (OED) contains a fluorinated polyurethane surface modifying macromolecule (Endexo™) blended in the membrane during manufacturing. Performance and safety of the dialyzer were assessed in a multi-center, open-label study (NCT# 03536663). This sub-analysis reports additional safety results for OED.

Methods

Subjects enrolled in the study underwent 12 HD treatments on the Optiflux® F160NR followed by 38 HD treatments (visits 13-50) with the OED. Safety was assessed by evaluating: 1) hematology tests and serum chemistry measured pre and post HD at the first use of OED and then measured pre HD for subsequent visits at approximately 2 weeks intervals; 2) Complement activation and serum albumin measured pre and post HD at the first use of OED; and 3) Adverse events recorded during the study.

Results

23 subjects were enrolled in the study of which 18 subjects (safety population [SPOP]) had at least one HD treatment with the OED for a total of 664 OED treatments. SPOP median age was 63.5 years, female (77.78%) and white (66.67%). Table 1 reports SPOP (n=18) mean (SD) for chemistry and hematology. An increase in mean serum albumin level from 3.94 to 4.23 g/dL was observed. No overt complement activation was noticed. Thirty-two AEs (4.8%) and 3 SAEs were reported, none were device related. No deaths or AEs leading to study discontinuation occurred.

Conclusion

The novel Optiflux EnexaTM dialyzer was well tolerated in a clinical study including 664 HD treatments in ESRD patients.

Funding

  • Commercial Support