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

KDL Inc.

Status and phase

Completed

Phase 2

Conditions

Chronic Kidney Disease

Hyperphosphatemia

Treatments

Dietary Supplement: Placebo

Dietary Supplement: HS219

Study type

Interventional

Funder types

Industry

Identifiers

NCT01039428

HS219CCR-001

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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