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

NCT01039428 | Completed Phase 2 Results DMC

• 1 other identifier: HS219CCR-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 11

Brief Summary

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

Hyperphosphatemia; Chronic Kidney Disease

Keywords

hyperphosphatemia; hemodialysis; chitosan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  week 3

• Salivary Inorganic Phosphorus Level

  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])

  week 3

Study Arms (2)

HS219

EXPERIMENTAL

Dietary Supplement: HS219

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

HS219 DIETARY_SUPPLEMENT

Chewing for 30 min three time a day far after meal

HS219

Placebo DIETARY_SUPPLEMENT

Chewing for 30 min three times a day far after meal

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KDL Inc.: lead

Study Sites (11)

Meiyo Clinic

Toyohashi, Aichi-ken, 441-8023, Japan

Location

Asahi General Hospital

Asahi, Chiba, 289-2511, Japan

Location

Japanese Red Cross Koga Hospital

Koga, Ibaragi, 306-0014, Japan

Location

Sumiyoshi Clinic Hospital

Mito, Ibaragi, 310-0844, Japan

Location

Toride Medical Center

Toride, Ibaragi, 302-0022, Japan

Location

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaragi, 300-0053, Japan

Location

Japanese Red Cross Suwa Hospital

Suda, Nagano, 392-8510, Japan

Location

Maruko General Hospital

Ueda, Nagano, 386-0493, Japan

Location

Komagome Kyouritsu Clinic

Tokyo, Tokyo, 113-0021, Japan

Location

Asagaya Suzuki Clinic

Tokyo, Tokyo, 166-0004, Japan

Location

Suda Clinic

Tokyo, Tokyo, 169-0075, Japan

Location

Related Publications (2)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

• 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.

  PMID: 24968790 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: KDL

toiawase@advance-cro.co.jp

818058844243

Study Officials

• Tadao Akizawa, MD

  Divison of Nephrology, Department of Medicine, Showa University School of Medicine

  STUDY CHAIR

• Masafumi Fukagawa, MD, PhD

  Divison of Nephrology and Metabolism, Tokai University School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2009
• First Posted: December 25, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 14, 2015
• Results First Posted: June 1, 2012

Record last verified: 2012-05

Locations

JP (11)