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

K

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

68 participants in 2 patient groups, including a placebo group

HS219
Experimental group
Treatment:
Dietary Supplement: HS219
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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