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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.
Nephrology (Carlton). 2011 Nov; 16(8):743-50.N

Abstract

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.

Authors+Show Affiliations

Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21854503

Citation

Chen, Jin-Bor, et al. "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." Nephrology (Carlton, Vic.), vol. 16, no. 8, 2011, pp. 743-50.
Chen JB, Chiang SS, Chen HC, et al. 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. Nephrology (Carlton). 2011;16(8):743-50.
Chen, J. B., Chiang, S. S., Chen, H. C., Obayashi, S., Nagasawa, M., Hexham, J. M., Balfour, A., Junge, G., Akiba, T., & Fukagawa, M. (2011). 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. Nephrology (Carlton, Vic.), 16(8), 743-50. https://doi.org/10.1111/j.1440-1797.2011.01509.x
Chen JB, et al. 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. Nephrology (Carlton). 2011;16(8):743-50. PubMed PMID: 21854503.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Chen,Jin-Bor, AU - Chiang,Shou-Shan, AU - Chen,Hung-Chun, AU - Obayashi,Seiichi, AU - Nagasawa,Masaki, AU - Hexham,J Mark, AU - Balfour,Alison, AU - Junge,Guido, AU - Akiba,Takashi, AU - Fukagawa,Masafumi, PY - 2011/8/23/entrez PY - 2011/8/23/pubmed PY - 2012/3/6/medline SP - 743 EP - 50 JF - Nephrology (Carlton, Vic.) JO - Nephrology (Carlton) VL - 16 IS - 8 N2 - 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. SN - 1440-1797 UR - https://www.unboundmedicine.com/medline/citation/21854503/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_ L2 - https://doi.org/10.1111/j.1440-1797.2011.01509.x DB - PRIME DP - Unbound Medicine ER -