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

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039428
• Other study ID #: HS219CCR-001
• Status: Completed
• Phase: Phase 2
• First received: December 24, 2009
• Last updated: August 31, 2015
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2012
• Source: KDL Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• HS219
Chewing for 30 min three time a day far after meal
• Placebo
Chewing for 30 min three times a day far after meal

Locations

Country	Name	City	State
Japan	Asahi General Hospital	Asahi	Chiba
Japan	Japanese Red Cross Koga Hospital	Koga	Ibaragi
Japan	Sumiyoshi Clinic Hospital	Mito	Ibaragi
Japan	Japanese Red Cross Suwa Hospital	Suda	Nagano
Japan	Asagaya Suzuki Clinic	Tokyo
Japan	Komagome Kyouritsu Clinic	Tokyo
Japan	Suda Clinic	Tokyo
Japan	Toride Medical Center	Toride	Ibaragi
Japan	Meiyo Clinic	Toyohashi	Aichi
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura	Ibaragi
Japan	Maruko General Hospital	Ueda	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
KDL Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL		baseline and end of the treatment	No
Secondary	Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ?P<5.5 mg/dL at Week 3		week 3	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No