Multicenter, randomized, placebo- controlled, double blind study of HS219 to evaluate the efficacy and safety in chronic kidney disease patients on hemodialysis with hyperphosphatemia - Study of HS219 in chronic kidney disease patients on hemodialysis with hyperphosphatemia

Start Date01 Dec 2009

Sponsor / Collaborator

Healthserve Ltd.

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01 Dec 2014·BMC NephrologyQ4 · MEDICINE

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

Q4 · MEDICINE

ArticleOA

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

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.TRIAL REGISTRATION[corrected] ClinicalTrials.gov NCT01039428, 24 December, 2009.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperphosphatemia	Phase 3	-	CM&D Pharma Ltd.	-
Hyperphosphatemia	Phase 3	-	University of Messina	-
Hyperphosphatemia	Phase 3	-	HealthServe, LLC	-

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