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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Hyperphosphatemia
• Intervention / Treatment: Dietary supplement: HS219; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 113-0021
    • Komagome Kyouritsu Clinic
  • Tokyo, Japan, 166-0004
    • Asagaya Suzuki Clinic
  • Tokyo, Japan, 169-0075
    • Suda Clinic
  • Aichi
    • Toyohashi, Aichi, Japan, 441-8023
      • Meiyo Clinic
  • Chiba
    • Asahi, Chiba, Japan, 289-2511
      • Asahi General Hospital
  • Ibaragi
    • Koga, Ibaragi, Japan, 306-0014
      • Japanese Red Cross Koga Hospital
    • Mito, Ibaragi, Japan, 310-0844
      • Sumiyoshi Clinic Hospital
    • Toride, Ibaragi, Japan, 302-0022
      • Toride Medical Center
    • Tsuchiura, Ibaragi, Japan, 300-0053
      • Tsuchiura Kyodo General Hospital
  • Nagano
    • Suda, Nagano, Japan, 392-8510
      • Japanese Red Cross Suwa Hospital
    • Ueda, Nagano, Japan, 386-0493
      • Maruko General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Chewing for 30 min three times a day far after meal
Experimental: HS219	Dietary supplement: HS219; Chewing for 30 min three time a day far after meal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KDL Inc.
• Investigators: 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

Publications and helpful links

General Publications

• Akizawa T, Tsuruta Y, Okada Y, Miyauchi Y, Suda A, Kasahara H, Sasaki N, Maeda Y, Suzuki T, Matsui N, Niwayama J, Suzuki T, Hara H, Asano Y, Komemushi S, Fukagawa M. Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2014 Jun 25;15:98. doi: 10.1186/1471-2369-15-98.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 24, 2009
• First Submitted That Met QC Criteria: December 24, 2009
• First Posted (Estimate): December 25, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: hemodialysis; hyperphosphatemia; chitosan
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
• Other Study ID Numbers: HS219CCR-001