title: Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride.
abstract: OBJECTIVE
  SBR759 is a calcium-free, polymeric, iron(III)-based oral phosphate binder, in development for the treatment of hyperphosphatemia. The efficacy and safety of SBR759 was compared with sevelamer hydrochloride in chronic kidney dialysis patients on hemodialysis.
  
  
  METHODS
  Japanese and Taiwanese hyperphosphatemic patients who were on hemodialysis (n = 203) received starting doses of 3.0 or 4.5 g/day SBR759 or 2.4 or 4.8 g/day sevelamer-hydrochloride (HCl) based on baseline phosphate levels. Daily doses were up-titrated every 2 weeks to reach the Kidney Disease Outcomes Quality Initiative (K/DOQI) recommended target serum phosphate concentration ≤1.7 mmol/L. The key endpoints were proportion of patients achieving target serum phosphate and the safety at week 12.
  
  
  RESULTS
  SBR759 showed a superior phosphate response at week 12 compared with sevelamer-HCl (83% vs 54% patients; P < 0.0001). Mean serum calcium concentrations were unaffected by either treatment. Similar incidences of adverse events and serious adverse events were seen with SBR759 and sevelamer-HCl (90.3% vs 94.1% and 5.2% vs 4.4%, respectively), but overall discontinuation rates were lower with SBR759 (11.9% vs 20.6%). The proportion of patients experiencing gastrointestinal disorders was lower in SBR759 versus sevelamer-HCl. No treatment-related serious adverse events were reported.
  
  
  CONCLUSIONS
  SBR759 showed superior phosphate control with a favorable tolerability profile compared to sevelamer-HCl in hemodialysis patients.
authors.affiliation: Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Jin-Bor
authors.initials: JB
authors.lastname: Chen
authors.forename: Shou-Shan
authors.initials: SS
authors.lastname: Chiang
authors.forename: Hung-Chun
authors.initials: HC
authors.lastname: Chen
authors.forename: Seiichi
authors.initials: S
authors.lastname: Obayashi
authors.forename: Masaki
authors.initials: M
authors.lastname: Nagasawa
authors.forename: J Mark
authors.initials: JM
authors.lastname: Hexham
authors.forename: Alison
authors.initials: A
authors.lastname: Balfour
authors.forename: Guido
authors.initials: G
authors.lastname: Junge
authors.forename: Takashi
authors.initials: T
authors.lastname: Akiba
authors.forename: Masafumi
authors.initials: M
authors.lastname: Fukagawa
mesh_terms: D000368:Aged; D044466:Asian People; D002118:Calcium / Q000378:metabolism; D002614:Chelating Agents / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000378:metabolism*; D011073:Polyamines / Q000008:administration & dosage* / Q000009:adverse effects; D006435:Renal Dialysis; D000069603:Sevelamer; D013213:Starch / Q000008:administration & dosage* / Q000009:adverse effects; D013624:Taiwan; D016896:Treatment Outcome
chemical_list: D002614:Chelating Agents; D004338:Drug Combinations; D005290:Ferric Compounds; D010710:Phosphates; D011073:Polyamines; C570356:SBR 759; D013213:Starch; D000069603:Sevelamer; D002118:Calcium