A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia - Full Text View

Purpose

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
Hyperphosphatemia Chronic Kidney Disease	Dietary Supplement: HS219 Dietary Supplement: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Chronic Kidney Disease Dialysis

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P＜5.5 mg/dL at Week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
Serum Inorganic Phosphorus Level [ Time Frame: week 3 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Ca×P [ Time Frame: week 3 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039428

Locations

Japan
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
Asagaya Suzuki Clinic
Tokyo, Japan, 166-0004
Suda Clinic
Tokyo, Japan, 169-0075
Komagome Kyouritsu Clinic
Tokyo, Japan, 113-0021

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	KDL Inc.
ClinicalTrials.gov 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:	June 5, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by KDL Inc.:

hyperphosphatemia
hemodialysis
chitosan

Additional relevant MeSH terms:

Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013