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

Autor: Shou-Shan Chiang, Masaki Nagasawa, Takashi Akiba, Jin-Bor Chen, J. Mark Hexham, Seiichi Obayashi, Hung-Chun Chen, Guido Junge, Masafumi Fukagawa, Alison Balfour
Rok vydání: 2011
Předmět:
Zdroj: Nephrology. 16:743-750
ISSN: 1320-5358
Popis: 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
Databáze: OpenAIRE