Kidney Week

Abstract: TH-PO242

Increased Dialyzer Membrane Hydrophilicity Improves Hemocompatibility and Performance: A Randomized Investigation

Session Information

• Hemodialysis, Hemodiafiltration, and Frequent Dialysis
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Ronova, Petra, Fresenius Nephrocare Praha 9, Praha, Czechia

Petra Ronova, MD, DrMed

• Krizsan, Maria, Péterfy II. Dialízis Központ, Budapest, Hungary

Maria Krizsan, MD

• Griesshaber, Bettina, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Bettina Griesshaber, PhD

• Erlenkoetter, Ansgar, Fresenius Medical Care Deutschland GmbH, Sankt Wendel, Saarland, Germany

Ansgar Erlenkoetter, PhD

• Zawada, Adam M., Fresenius Medical Care Deutschland GmbH, Sankt Wendel, Saarland, Germany

Adam M. Zawada, PhD

• Nitschel, Robert, Fresenius Medical Care Deutschland GmbH, Sankt Wendel, Saarland, Germany

Robert Nitschel, MSc

• Ottillinger, Bertram, Ottillinger Life Sciences, Brunnthal (Munich), Germany

Bertram Ottillinger, DrMed

• Zhao, Bingbin, Fresenius Medical Care, Beijing, China

Bingbin Zhao, MD

• Korolev, Natalia, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Natalia Korolev

• Braun, Jennifer, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Jennifer Braun, PhD

• Larkin, John W., Fresenius Medical Care, Waltham, Massachusetts, United States

John W. Larkin, PhD

• Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Manuela Stauss-Grabo, PhD

Background

Dialyzer performance and hemocompatibility can get compromised during treatment due to adsorption of plasma proteins to the membrane. Increased membrane hydrophilicity reduces membrane fouling and was implemented in the novel FX CorAL dialyzer. In a randomized trial we investigated the performance and hemocompatibility profiles of the FX CorAL dialyzer vs. two comparators during post-dilution online hemodiafiltration (HDF).

Methods

This prospective, multicentric, crossover study with 4-week randomized treatment sequences compared the FX CorAL 600 vs. FX CorDiax 600 (both Fresenius Medical Care Germany) and xevonta Hi 15 (B. Braun). Primary outcome was β2-microglobulin removal rate (β2-m RR). Secondary endpoints were RR and clearance of small and middle molecules, and intra-/interdialytic profiles of hemocompatibility markers. Further endpoints were patient reported outcomes (PROs) and clinical safety.

Results

82 subjects (76 Intention-to-treat group) were enrolled. FX CorAL showed the highest β2-m RR (76.28%), followed by FX CorDiax (75.69%) and xevonta (74.48%), which was non-inferior to both comparators (p<0.0001 each) and superior to xevonta (p<0.0001). Secondary endpoints related to middle molecules affirmed these results; small molecule performance was comparable between dialyzers. For intradialytic hemocompatibility, the typical drop in leucocytes, monocyte, and neutrophil during dialysis as well as the rise of complement, cell and platelet activation markers were lower during treatment with FX CorAL vs comparators (Figure 1). There were no differences in interdialytic hemocompatibility, PROs, or clinical safety.

Conclusion

During HDF, the novel FX CorAL with increased membrane hydrophilicity showed high performance and a favorable hemocompatibility profile as compared to other commonly used dialyzers. Further long-term investigations are warranted to examine if the benefits of FX CorAL translate into improved cardiovascular and mortality endpoints.

Funding

• Commercial Support – Fresenius Medical Care Deutschland GmbH