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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
Author(s) -
CHEN JINBOR,
CHIANG SHOUSHAN,
CHEN HUNGCHUN,
OBAYASHI SEIICHI,
NAGASAWA MASAKI,
HEXHAM J MARK,
BALFOUR ALISON,
JUNGE GUIDO,
AKIBA TAKASHI,
FUKAGAWA MASAFUMI
Publication year - 2011
Publication title -
nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.752
H-Index - 61
eISSN - 1440-1797
pISSN - 1320-5358
DOI - 10.1111/j.1440-1797.2011.01509.x
Subject(s) - sevelamer , medicine , hyperphosphatemia , phosphate binder , hemodialysis , adverse effect , tolerability , dialysis , kidney disease , gastroenterology , urology , phosphate , discontinuation , chemistry , organic chemistry
Aim: 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.