A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.

Inclusion Criteria:

• Written informed consent given
• Able to comply with the study procedures and medication
• On a stable HD regimen (at least 3 x per week) for ≥ 3 months
• Subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month
• A mean serum inorganic phosphorous in the previous 3 tests : > 5.5 mg/dL and < 9.0 mg/dL
• Removal rate of blood urea nitrogen (BUN) ≥ 60%
• Rate of salivary flow by Saxon test ≥ 1 g/2 min

Exclusion Criteria:

• Blood purification therapy other than HD
• Current clinically significant intestinal motility disorder
• Possible parathyroid intervention during the study period
• History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia
• History of allergy against active ingredient
• Receipt of any investigational drug within 30 days of informed consent