title: Randomized controlled open-label trial of vitamin E-bonded polysulfone dialyzer and erythropoiesis-stimulating agent response.
abstract: OBJECTIVE
  A 1-year multicenter prospective randomized controlled study was conducted on the effects of vitamin E-bonded polysulfone dialyzers on erythropoiesis-stimulating agent response in hemodialysis patients.
  
  
  METHODS
  Major inclusion criteria were use of high-flux polysulfone dialyzers with 50-70 ml/min β2-microglobulin clearance over 3 months, transferrin saturation over 20%, same erythropoiesis-stimulating agent for over 3 months, and hemoglobin at 10-12 g/dl. Hemodialysis patients were placed in four interventional groups: two hemoglobin ranges (10.0-10.9 or 11.0-11.9 g/dl) and two dialyzers. Patients were randomly assigned by central registration to a vitamin E-bonded polysulfone dialyzers or polysulfone control group. Primary end point was relative erythropoiesis resistance index at baseline between groups at 12 months. Erythropoiesis resistance index was defined as total weekly erythropoiesis-stimulating agent dose divided by hemoglobin.
  
  
  RESULTS
  There were no statistically significant differences in age or sex. There was no significant difference in relative erythropoiesis resistance index between vitamin E-bonded polysulfone dialyzers and control groups at 12 months (vitamin E-bonded polysulfone dialyzers: 1.1, control: 1.3). The vitamin E-bonded polysulfone dialyzers group showed better relative erythropoiesis resistance index than the control group at 11.0-11.9 g/dl hemoglobin (vitamin E-bonded polysulfone dialyzers: 1.0, control: 1.4 at 12 months, significant difference) but no difference at 10.0-10.9 g/dl hemoglobin.
  
  
  CONCLUSIONS
  The overall relative erythropoiesis resistance index showed no difference between the vitamin E-bonded polysulfone dialyzers and control groups, although the change in relative erythropoiesis resistance index differed according to hemoglobin level.
authors.affiliation: Lifestyle Disease and CKD Center, Edogawa General Hospital, Tokyo, Japan. tsnk@ckdnet.com
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sanaka
authors.forename: Takahiro
authors.initials: T
authors.lastname: Mochizuki
authors.forename: Eriko
authors.initials: E
authors.lastname: Kinugasa
authors.forename: Eiji
authors.initials: E
authors.lastname: Kusano
authors.forename: Shigeru
authors.initials: S
authors.lastname: Ohwada
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Kuno
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Kojima
authors.forename: Shuzo
authors.initials: S
authors.lastname: Kobayashi
authors.forename: Minoru
authors.initials: M
authors.lastname: Satoh
authors.forename: Noriaki
authors.initials: N
authors.lastname: Shimada
authors.forename: Kazushi
authors.initials: K
authors.lastname: Nakao
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Nakazawa
authors.forename: Hideki
authors.initials: H
authors.lastname: Nishimura
authors.forename: Eisei
authors.initials: E
authors.lastname: Noiri
authors.forename: Takashi
authors.initials: T
authors.lastname: Shigematsu
authors.forename: Tadashi
authors.initials: T
authors.lastname: Tomo
authors.forename: Teiryo
authors.initials: T
authors.lastname: Maeda
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000975:Antioxidants / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D004920:Erythropoiesis / Q000187:drug effects*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007564:Japan; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D011108:Polymers; D011446:Prospective Studies; D006435:Renal Dialysis / Q000295:instrumentation*; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D013450:Sulfones; D013997:Time Factors; D016896:Treatment Outcome; D014810:Vitamin E / Q000008:administration & dosage*
chemical_list: D000975:Antioxidants; D015415:Biomarkers; D020099:Coated Materials, Biocompatible; D006397:Hematinics; D006454:Hemoglobins; D008567:Membranes, Artificial; D011108:Polymers; D013450:Sulfones; D014810:Vitamin E; C017662:polysulfone P 1700