Background: HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on\nto available phosphorus binders. We performed a randomized, placebo-controlled, double-blind study to evaluate\nthe efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to\nphosphorus binders.\nMethods: Sixty-eight HD patients who were maintained on calcium carbonate (n = 33) or sevelamer\nhydrochloride (n = 35) were enrolled. The primary end point was a change in serum phosphorus levels. Secondary\nend points included changes in levels of salivary phosphorus, serum calcium, parathyroid hormone (PTH), and\nintact fibroblast growth factor (iFGF) 23.\nResults: Sixty-three patients chewed either HS219 (n = 35) or placebo (n = 28) for 30 min, three times a day, for\n3 weeks. HS219 was well tolerated and safe. However, HS219 was not superior to placebo with additional\nreduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period. There were\nno significant effects of HS219 on reduction of salivary phosphorus, serum calcium, iPTH, or iFGF23 levels.\nConclusions: The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in\nJapanese HD patients with hyperphosphatemia. Our findings do not support previous findings that 20 mg of\nchitosan-loaded chewing gum reduces serum and salivary phosphorus levels.
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