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Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial.
BMC Nephrol. 2014 Jun 25; 15:98.BN

Abstract

BACKGROUND

HS219 (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.

METHODS

Sixty-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.

RESULTS

Sixty-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.

CONCLUSIONS

The 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.

Authors+Show Affiliations

Showa University School of Medicine, Tokyo, Japan. akizawa@med.showa-u.ac.jp.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 availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24968790

Citation

Akizawa, Tadao, et al. "Effect of Chitosan Chewing Gum On Reducing Serum Phosphorus in Hemodialysis Patients: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial." BMC Nephrology, vol. 15, 2014, p. 98.
Akizawa T, Tsuruta Y, Okada Y, et al. Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2014;15:98.
Akizawa, T., Tsuruta, Y., Okada, Y., Miyauchi, Y., Suda, A., Kasahara, H., Sasaki, N., Maeda, Y., Suzuki, T., Matsui, N., Niwayama, J., Suzuki, T., Hara, H., Asano, Y., Komemushi, S., & Fukagawa, M. (2014). Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial. BMC Nephrology, 15, 98. https://doi.org/10.1186/1471-2369-15-98
Akizawa T, et al. Effect of Chitosan Chewing Gum On Reducing Serum Phosphorus in Hemodialysis Patients: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial. BMC Nephrol. 2014 Jun 25;15:98. PubMed PMID: 24968790.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial. AU - Akizawa,Tadao, AU - Tsuruta,Yoshinari, AU - Okada,Yoichi, AU - Miyauchi,Yoshihiro, AU - Suda,Akio, AU - Kasahara,Hiroshi, AU - Sasaki,Nobuhiro, AU - Maeda,Yoshitaka, AU - Suzuki,Takako, AU - Matsui,Noriaki, AU - Niwayama,Jun, AU - Suzuki,Toshiaki, AU - Hara,Hideaki, AU - Asano,Yasushi, AU - Komemushi,Sadao, AU - Fukagawa,Masafumi, Y1 - 2014/06/25/ PY - 2014/01/28/received PY - 2014/06/18/accepted PY - 2014/6/28/entrez PY - 2014/6/28/pubmed PY - 2014/12/15/medline SP - 98 EP - 98 JF - BMC nephrology JO - BMC Nephrol VL - 15 N2 - BACKGROUND: HS219 (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. METHODS: Sixty-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. RESULTS: Sixty-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. CONCLUSIONS: The 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. SN - 1471-2369 UR - https://www.unboundmedicine.com/medline/citation/24968790/Effect_of_chitosan_chewing_gum_on_reducing_serum_phosphorus_in_hemodialysis_patients:_a_multi_center_randomized_double_blind_placebo_controlled_trial_ L2 - https://www.biomedcentral.com/1471-2369/15/98 DB - PRIME DP - Unbound Medicine ER -