PT - JOURNAL ARTICLE AU - Ehlerding, Götz AU - Erlenkötter, Ansgar AU - Gauly, Adelheid AU - Griesshaber, Bettina AU - Kennedy, James AU - Rauber, Lena AU - Ries, Wolfgang AU - Schmidt-Gürtler, Hans AU - Stauss-Grabo, Manuela AU - Wagner, Stephan AU - Zawada, Adam M. AU - Zschätzsch, Sebastian AU - Kempkes-Koch, Manuela TI - Performance and hemocompatibility of a novel polysulfone dialyzer: a randomized controlled trial AID - 10.34067/KID.0000302021 DP - 2021 Jan 01 TA - Kidney360 PG - 10.34067/KID.0000302021 4099 - http://kidney360.asnjournals.org/content/early/2021/04/07/KID.0000302021.short 4100 - http://kidney360.asnjournals.org/content/early/2021/04/07/KID.0000302021.full AB - We investigated the performance and hemocompatibility of a new polysulfone hemodialyzer with enhanced membrane properties.β2-microglobulin removal rate, was non-inferior to both comparator dialyzers and superior to a cellulose-acetate based dialyzer.The dialyzer showed a favorable hemocompatibility profile based on markers for complement, cell and contact activation, and coagulation.Background: High-flux dialyzers shall effectively remove uremic toxins and be hemocompatible to minimize intradialytic humoral and cellular stimulation and long-term impact on patient outcomes. A new dialyzer with a modified membrane surface has been tested for performance and hemocompatibility. Methods: This multicenter, prospective, randomized, cross-over study applied for one week each the new polysulfone-based FX CorAL 600 (Fresenius Medical Care, Bad Homburg, Germany), the polyarylethersulfone-based Polyflux 170H (Baxter Healthcare Corporation, Deerfield, IL, USA) and the cellulose-triacetate-based SureFluxTM 17UX (Nipro Medical Europe, Mechelen, Belgium) to assess non-inferiority of removal rate of β2-microglobulin of the FX CorAL 600. Performance was assessed by removal rate and clearance of small and middle molecules. Hemocompatibility was assessed through markers of complement, cell activation, contact activation and coagulation. Results: Of 70 patients, 58 comprised the intention-to-treat population. The removal rate of β2-microglobulin of the FX CorAL 600 was non-inferior to both comparators (P<0.0001 vs SureFluxTM 17UX; P=0.0006 vs Polyflux 170H), and superior to SureFluxTM 17UX. The activation of C3a and C5a with FX CorAL 600 was significantly lower 15 min after treatment start than with SureFluxTM 17UX. The activation of sC5b-9 with FX CorAL 600 was significantly lower over the whole treatment than with SureFluxTM 17UX, and lower after 60 min than with Polyflux 170H. The treatments with FX CorAL 600 were well tolerated. Conclusions: FX CorAL 600 efficiently removed small and middle molecules, showed a favorable hemocompatibility profile and was associated with a low frequency of adverse events in the present study with a limited patient number and follow-up time. Further studies with longer observation times are warranted to provide further evidence supporting the use of the new dialyzer in a wide range of therapeutic options and long-term treatments of hemodialysis patients to minimize the potential impact on inflammatory processes.