A microdomain-structured synthetic high-flux hollow-fiber membrane for renal replacement therapy

A prospective crossover clinical study evaluated solute removal and biocomp atibility of a tailored, hydrophobic-hydrophilic microdomain structure prod uced from a blend of polyamide, polyarylethersulfone, and polyvinylpyrrolid one (Polyflux) compared with Fresenius Polysulfone in dialyzers of similar surface area. The clearance of small molecules (urea, creatinine, and phosp hate) for both membranes was comparable. plasma levels of beta (2) microglo bulin were reduced at the end of treatment with both membranes (49.8% of pr etreatment values for Polyflux; 45.9%, Fresenius Polysulfone) and was assoc iated with the recovery of 207 +/- 84 mg of beta (2) microglobulin from the dialyzing fluid for Polyflux compared with 147 +/- 29 for Fresenius Polysu lfone (p = 0.12). The dialyzing fluid also contained 7,758 mg of protein wh en using Polyflux compared with 7,793 mg using Fresenius Potysulfone (stand ard error of difference for any pair was 511 mg). No albumin was present in the dialysis fluid for either membrane. Neutropenia, platelet adhesion to the membrane, and complement activation characterized by C3a, C5a, and SC5b -9 generation were slight and independent of membrane type. Membrane thromb us generating potential measured by thrombin:antithrombin III were also sim ilar. These results indicate that the tailored, hydrophobic-hydrophilic mic rodomain structure of the membrane results in a favorable biocompatibility profile and clinically acceptable solute removal similar to the widely used Fresenius PolysuIfone membrane.