Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial.

Tadao Akizawa,Jun Niwayama,Yoshihiro Miyauchi,Yasushi Asano,Nobuhiro Sasaki,Akio Suda,Yoshinari Tsuruta,Toshiaki Suzuki,Masafumi Fukagawa,Noriaki Matsui,Hiroshi Kasahara,Takako Suzuki,Sadao Komemushi,Yoichi Okada,Hideaki Hara,Yoshitaka Maeda

doi:10.1186/1471-2369-15-98

Abstract

BackgroundHS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders. We performed a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to phosphorus binders.MethodsSixty-eight HD patients who were maintained on calcium carbonate (n = 33) or sevelamer hydrochloride (n = 35) were enrolled. The primary end point was a change in serum phosphorus levels. Secondary end points included changes in levels of salivary phosphorus, serum calcium, parathyroid hormone (PTH), and intact fibroblast growth factor (iFGF) 23.ResultsSixty-three patients chewed either HS219 (n = 35) or placebo (n = 28) for 30 min, three times a day, for 3 weeks. HS219 was well tolerated and safe. However, HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period. There were no significant effects of HS219 on reduction of salivary phosphorus, serum calcium, iPTH, or iFGF23 levels.ConclusionsThe chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia. Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels.Trail registrationClinicalTrials.gov NCT01039428, 24 December, 2009.

Highlights

HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders
end-stage renal disease (ESRD) patients with hyperphosphatemia who were poorly controlled by phosphorus binders were recruited from 11 study sites in Japan from December 2009 to June 2010
HS219 was developed as a supplementary food for chronic kidney disease and ESRD patients with hyperphosphatemia who are treated with phosphorus binders

Summary

Introduction

HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders. Placebo-controlled, double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to phosphorus binders. Cardiovascular disease is the most common cause of death in patients with end-stage renal disease (ESRD) who are undergoing hemodialysis (HD) [1]. Increased levels of serum phosphorus in HD patients are associated with an increased incidence and mortality of cardiovascular diseases [2]. HD and restriction of dietary phosphorus result in insufficient control of serum phosphorus [3]. Salivary phosphorus levels are higher than those in serum, in patients with chronic kidney disease [6] and ESRD [7]. Salivary phosphorus is an alternate source of phosphorus which should not be ignored, and could be a novel target for a novel phosphorus restriction

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