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

Study Overview
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Brief Summary
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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.

Conditions
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Hyperphosphatemia, Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: HS219
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HS219<br> | Dietary Supplement: HS219<br>* Chewing for 30 min three time a day far after meal<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Chewing for 30 min three times a day far after meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline | Change in serum inorganic phosphorus at the end of treatment from baseline | baseline and end of the chewing treatment during three week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL |  | baseline and end of the treatment | 
| Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3 |  | week 3 | 
| Serum Inorganic Phosphorus Level | Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | week 3 | 
| Salivary Inorganic Phosphorus Level | Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | week 3 | 
| Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL]) | Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | week 3 | 
| Ca×P | Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | week 3 | 
| Serum Intact Parathyroid Hormone (PTH) Level | Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | week 3 | 
| Serum Intact Fibroblast Growth Factor (FGF) 23 Level | Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperphosphatemia, hemodialysis, chitosan