title: Hemodialysis clearance of iosimenol, a novel iso-osmolar radiographic contrast medium.
abstract: BACKGROUND
  Iodinated contrast media (CM) have molecular and pharmacokinetic properties likely to make them highly dialyzable. Controlled clinical studies allowing for comparisons of hemodialysis clearance between different test substances and in multiple hemodialysis filters are, however, complex and not always practically feasible. A miniaturized in vitro method was therefore developed to evaluate the dialyzability of a new CM.
  
  
  OBJECTIVE
  To evaluate hemodialysis clearance of iosimenol, a novel iso-osmolar contrast medium (CM), in a select variety of hemodialysis filters and in comparison to commercially available CM.
  
  
  METHODS
  Three different high-flux and one low-flux membrane were used in miniaturized dialyzers to evaluate the in vitro blood clearance of iosimenol. Commercially available CM (iodixanol and iohexol) served as control substances. In vitro dialysis parameters were then used to predict clinical hemodialysis clearances. Residual ratios of endogenous substances (inorganic phosphate, urea nitrogen, creatinine, total bilirubin, and albumin) were used as proof of reliability of the in vitro dialysis system.
  
  
  RESULTS
  Dialyzable small endogenous molecules were readily eliminated in all membranes. The removal ratios of iosimenol were generally similar to that of iodixanol in all membranes except the high-flux polysulfone but were consistently lower than that of iohexol. The blood clearance of iosimenol during clinical hemodialysis was predicted as, on average, approximately 85 mL/min with the high-flux membranes and 47 mL/min with the low-flux membrane.
  
  
  CONCLUSIONS
  The dialyzability of iosimenol was evaluated using a newly developed in vitro dialysis system, and iosimenol was readily cleared from blood with all four tested membranes. And it is suggested that the dialysis parameters can predict clinical hemodialysis clearance of CM.
authors.affiliation: Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd., Tokushima, Japan.
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Hirao
authors.affiliation: Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd., Tokushima, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Kashiyama
authors.affiliation: Tokushima Research Institute, Otsuka Pharmaceutical Co., Ltd., Tokushima, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Umehara
authors.affiliation: Department of Bio Research, Kamakura Techno-Science, Inc., Kanagawa, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kohno
authors.affiliation: Otsuka International Asia Arab Division, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Ikei
authors.affiliation: Otsuka Novel Product, Medical Imaging, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA barry.hogstrom@otsuka-us.com.
authors.forename: Barry
authors.initials: B
authors.lastname: Hogstrom
mesh_terms: D001549:Benzamides / Q000493:pharmacokinetics*; D003287:Contrast Media / Q000493:pharmacokinetics*; D005374:Filtration / Q000295:instrumentation; D006801:Humans; D011412:Propanolamines / Q000493:pharmacokinetics*; D006435:Renal Dialysis / Q000295:instrumentation / Q000379:methods*; D015203:Reproducibility of Results
chemical_list: D001549:Benzamides; D003287:Contrast Media; D011412:Propanolamines; C450045:iosmin
keywords: Contrast media; iodixanol; iohexol; iosimenol