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

This study has been completed.
Information provided by (Responsible Party):
KDL Inc. Identifier:
First received: December 24, 2009
Last updated: August 31, 2015
Last verified: May 2012
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.

Condition Intervention Phase
Chronic Kidney Disease
Dietary Supplement: HS219
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by KDL Inc.:

Primary Outcome Measures:
  • Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline [ Time Frame: baseline and end of the chewing treatment during three week treatment period ]
    Change in serum inorganic phosphorus at the end of treatment from baseline

Secondary Outcome Measures:
  • Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL [ Time Frame: baseline and end of the treatment ]
  • Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3 [ Time Frame: week 3 ]
  • Serum Inorganic Phosphorus Level [ Time Frame: week 3 ]
    Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  • Salivary Inorganic Phosphorus Level [ Time Frame: week 3 ]
    Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  • 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]) [ Time Frame: week 3 ]
    Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  • Ca×P [ Time Frame: week 3 ]
    Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  • Serum Intact Parathyroid Hormone (PTH) Level [ Time Frame: week 3 ]
    Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  • Serum Intact Fibroblast Growth Factor (FGF) 23 Level [ Time Frame: week 3 ]
    Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Enrollment: 68
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HS219 Dietary Supplement: HS219
Chewing for 30 min three time a day far after meal
Placebo Comparator: Placebo Dietary Supplement: Placebo
Chewing for 30 min three times a day far after meal


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01039428

Meiyo Clinic
Toyohashi, Aichi, Japan, 441-8023
Asahi General Hospital
Asahi, Chiba, Japan, 289-2511
Japanese Red Cross Koga Hospital
Koga, Ibaragi, Japan, 306-0014
Sumiyoshi Clinic Hospital
Mito, Ibaragi, Japan, 310-0844
Toride Medical Center
Toride, Ibaragi, Japan, 302-0022
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaragi, Japan, 300-0053
Japanese Red Cross Suwa Hospital
Suda, Nagano, Japan, 392-8510
Maruko General Hospital
Ueda, Nagano, Japan, 386-0493
Komagome Kyouritsu Clinic
Tokyo, Japan, 113-0021
Asagaya Suzuki Clinic
Tokyo, Japan, 166-0004
Suda Clinic
Tokyo, Japan, 169-0075
Sponsors and Collaborators
KDL Inc.
Study Chair: Tadao Akizawa, MD Divison of Nephrology, Department of Medicine, Showa University School of Medicine
Study Director: Masafumi Fukagawa, MD, PhD Divison of Nephrology and Metabolism, Tokai University School of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: KDL Inc. Identifier: NCT01039428     History of Changes
Other Study ID Numbers: HS219CCR-001
Study First Received: December 24, 2009
Results First Received: February 29, 2012
Last Updated: August 31, 2015

Keywords provided by KDL Inc.:

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases processed this record on May 22, 2017