Background: High-flux dialyzers effectively remove uremic toxins, are hemocompatible to minimize intradialytic humoral and cellular stimulation, and have long-term effects on patient outcomes. A new dialyzer with a modified membrane surface has been tested for performance and hemocompatibility. Methods: This multicenter, prospective, randomized, crossover study involved the application of the new polysulfone-based FX CorAL 600 (Fresenius Medical Care, Bad Homburg, Germany), the polyarylethersulfone-based Polyflux 170H (Baxter Healthcare Corporation, Deerfield, IL), and the cellulose triacetate-based SureFlux 17UX (Nipro Medical Europe, Mechelen, Belgium), for 1 week each, to assess the noninferiority of the FX CorAL 600's removal rate of β2-microglobulin. Performance was assessed by removal rate and clearance of small- and medium-sized molecules. Hemocompatibility was assessed through markers of complement, cell activation, contact activation, and coagulation. Results: Of 70 patients, 58 composed the intention-to-treat population. The FX CorAL 600's removal rate of β2-microglobulin was noninferior to both comparators (P<0.001 versus SureFlux 17UX; P=0.0006 versus Polyflux 170H), and superior to the SureFlux 17UX. The activation of C3a and C5a with FX CorAL 600 was significantly lower 15 minutes after treatment start than with SureFlux 17UX. The activation of sC5b-9 with FX CorAL 600 was significantly lower over the whole treatment than with SureFlux 17UX, and lower after 60 minutes than with the Polyflux 170H. The treatments with FX CorAL 600 were well tolerated. Conclusions: FX CorAL 600 efficiently removed small- and medium-sized molecules, showed a favorable hemocompatibility profile, and was associated with a low frequency of adverse events in this 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 for long-term treatment of patients on hemodialysis, to minimize the potential effects on inflammatory processes.
Background: High-flux dialyzers effectively remove uremic toxins, are hemocompatible to minimize intradialytic humoral and cellular stimulation, and have long-term effects on patient outcomes. A new dialyzer with a modified membrane surface has been tested for performance and hemocompatibility. Methods: This multicenter, prospective, randomized, crossover study involved the application of the new polysulfone-based FX CorAL 600 (Fresenius Medical Care, Bad Homburg, Germany), the polyarylethersulfone-based Polyflux 170H (Baxter Healthcare Corporation, Deerfield, IL), and the cellulose triacetate-based SureFlux 17UX (Nipro Medical Europe, Mechelen, Belgium), for 1 week each, to assess the noninferiority of the FX CorAL 600's removal rate of β2-microglobulin. Performance was assessed by removal rate and clearance of small- and medium-sized molecules. Hemocompatibility was assessed through markers of complement, cell activation, contact activation, and coagulation. Results: Of 70 patients, 58 composed the intention-to-treat population. The FX CorAL 600's removal rate of β2-microglobulin was noninferior to both comparators (P<0.001 versus SureFlux 17UX; P=0.0006 versus Polyflux 170H), and superior to the SureFlux 17UX. The activation of C3a and C5a with FX CorAL 600 was significantly lower 15 minutes after treatment start than with SureFlux 17UX. The activation of sC5b-9 with FX CorAL 600 was significantly lower over the whole treatment than with SureFlux 17UX, and lower after 60 minutes than with the Polyflux 170H. The treatments with FX CorAL 600 were well tolerated. Conclusions: FX CorAL 600 efficiently removed small- and medium-sized molecules, showed a favorable hemocompatibility profile, and was associated with a low frequency of adverse events in this 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 for long-term treatment of patients on hemodialysis, to minimize the potential effects on inflammatory processes.
Authors: Elisabeth Hertle; Marleen M van Greevenbroek; Ilja C Arts; Carla J van der Kallen; Stefan L Geijselaers; Edith J Feskens; Eugene H Jansen; Casper G Schalkwijk; Coen D Stehouwer Journal: Thromb Haemost Date: 2014-02-06 Impact factor: 5.249
Authors: Suetonia C Palmer; Kannaiyan S Rabindranath; Jonathan C Craig; Paul J Roderick; Francesco Locatelli; Giovanni F M Strippoli Journal: Cochrane Database Syst Rev Date: 2012-09-12
Authors: S Stefoni; L Colì; G Cianciolo; G Donati; G Ruggeri; E Ramazzotti; R Pohlmeier; D Lang Journal: Int J Artif Organs Date: 2003-01 Impact factor: 1.595
Authors: Francisco Maduell; Victor Navarro; Ma Carmen Cruz; Eduardo Torregrosa; Daniel Garcia; Victoria Simon; Jose Antonio Ferrero Journal: Am J Kidney Dis Date: 2002-09 Impact factor: 8.860
Authors: Pascal Melchior; Ansgar Erlenkötter; Adam M Zawada; Dirk Delinski; Christian Schall; Manuela Stauss-Grabo; James P Kennedy Journal: Artif Organs Date: 2021-02-13 Impact factor: 3.094
Authors: Karlien François; Christelle Orlando; Kristin Jochmans; Wilfried Cools; Vicky De Meyer; Christian Tielemans; Karl Martin Wissing Journal: Kidney Int Rep Date: 2020-03-13
Authors: Götz Ehlerding; Wolfgang Ries; Manuela Kempkes-Koch; Ekkehard Ziegler; Ansgar Erlenkötter; Adam M Zawada; James P Kennedy; Bertram Ottillinger; Manuela Stauss-Grabo; Thomas Lang Journal: Clin Kidney J Date: 2021-10-05