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Abstract: SA-PO416

Safety and Performance of the Clearum™ High Flux Hemodialyzer

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Krueger, Thilo, DaVita Clinical Research Deutschland GmbH, Düsseldorf, NRW, Germany
  • Dellanna, Frank, DaVita Clinical Research Deutschland GmbH, Düsseldorf, NRW, Germany
  • Kleophas, Werner, DaVita Clinical Research Deutschland GmbH, Düsseldorf, NRW, Germany
  • Mcclure, Candace, North American Science Associates Inc, Northwood, Ohio, United States
  • Manfredini, Silvia, Medtronic Inc, Mirandola, Italy
Background

Clearum™ is a new high flux steam sterilized (HS) dialyzer for treatment of end stage renal disease (ESRD) patients with hemodialysis (HD) or hemodiafiltration (HDF) online. A clinical study was conducted to evaluate the safety and performance of the Clearum HS hemodialyzer in the removal of small and middle-sized uremic toxins.

Methods

A prospective, interventional, non-randomized study enrolled twenty (20) ESRD patients undergoing HD. The Clearum HS dialyzer was compared to Fresenius FX-series of dialyzers for a baseline (control) comparison. The duration of the trial was 2 weeks for the FX control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.

Results

Nineteen (19) of 20 subjects completed the study. The primary objective of mean urea reduction ratio (URR) >65% was met. No significant difference in mean URR between the Clearum HS and Fresenius FX-series of dialyzers (p=0.97) was observed. No dialyzer-related adverse events were reported in the study. β-2-microglobulin (B2M) reduction with the Clearum HS dialyzer was statistically higher than the FX-series dialyzer (67.0% versus 54.1%; p<0.0001). Pre-dialysis interleukin-6 (IL6) and C-reactive protein (CRP) concentrations, blood-rest scores and thrombin-anti-thrombin (TAT) were comparable among the Clearum HS and FX-series of dialyzers. Finally, albumin remained at a stable level over the course of the 6 weeks of Clearum HS dialyzer use with no appreciable differences when compared to the Fresenius FX-series of dialyzers.

Conclusion

Overall, the Clearum HS dialyzer performed effectively in this post market study and with no reported dialyzer-related adverse events.

Funding

  • Commercial Support