Title
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Phase
Phase 2Lead Sponsor
KDL Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hyperphosphatemia Chronic Kidney DiseaseIntervention/Treatment
chitosan ...Study Participants
68This 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.
Chewing for 30 min three times a day far after meal
Chewing for 30 min three time a day far after meal
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
| Event Type | Organ System | Event Term | HS219 | Placebo |
|---|
Change in serum inorganic phosphorus at the end of treatment from baseline
Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
