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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


  • 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

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.


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.


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.


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


  • Commercial Support – Medtronic