Back to resultsA Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Primary Purpose
Hyperphosphatemia, Chronic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
HS219
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring hyperphosphatemia, hemodialysis, chitosan
Eligibility 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
Sites / Locations
- Meiyo Clinic
- Asahi General Hospital
- Japanese Red Cross Koga Hospital
- Sumiyoshi Clinic Hospital
- Toride Medical Center
- Tsuchiura Kyodo General Hospital
- Japanese Red Cross Suwa Hospital
- Maruko General Hospital
- Komagome Kyouritsu Clinic
- Asagaya Suzuki Clinic
- Suda Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HS219
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
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
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at 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).
Salivary Inorganic Phosphorus Level
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])
Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Ca×P
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
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
Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01039428
Brief Title
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KDL Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Chronic Kidney Disease
Keywords
hyperphosphatemia, hemodialysis, chitosan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HS219
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
HS219
Intervention Description
Chewing for 30 min three time a day far after meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Chewing for 30 min three times a day far after meal
Primary Outcome Measure Information:
Title
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL
Time Frame
baseline and end of the treatment
Title
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3
Time Frame
week 3
Title
Serum Inorganic Phosphorus Level
Description
Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time Frame
week 3
Title
Salivary Inorganic Phosphorus Level
Description
Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time Frame
week 3
Title
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])
Description
Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time Frame
week 3
Title
Ca×P
Description
Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time Frame
week 3
Title
Serum Intact Parathyroid Hormone (PTH) Level
Description
Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time Frame
week 3
Title
Serum Intact Fibroblast Growth Factor (FGF) 23 Level
Description
Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
Time Frame
week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadao Akizawa, MD
Organizational Affiliation
Divison of Nephrology, Department of Medicine, Showa University School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Masafumi Fukagawa, MD, PhD
Organizational Affiliation
Divison of Nephrology and Metabolism, Tokai University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Meiyo Clinic
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8023
Country
Japan
Facility Name
Asahi General Hospital
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Japanese Red Cross Koga Hospital
City
Koga
State/Province
Ibaragi
ZIP/Postal Code
306-0014
Country
Japan
Facility Name
Sumiyoshi Clinic Hospital
City
Mito
State/Province
Ibaragi
ZIP/Postal Code
310-0844
Country
Japan
Facility Name
Toride Medical Center
City
Toride
State/Province
Ibaragi
ZIP/Postal Code
302-0022
Country
Japan
Facility Name
Tsuchiura Kyodo General Hospital
City
Tsuchiura
State/Province
Ibaragi
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
Japanese Red Cross Suwa Hospital
City
Suda
State/Province
Nagano
ZIP/Postal Code
392-8510
Country
Japan
Facility Name
Maruko General Hospital
City
Ueda
State/Province
Nagano
ZIP/Postal Code
386-0493
Country
Japan
Facility Name
Komagome Kyouritsu Clinic
City
Tokyo
ZIP/Postal Code
113-0021
Country
Japan
Facility Name
Asagaya Suzuki Clinic
City
Tokyo
ZIP/Postal Code
166-0004
Country
Japan
Facility Name
Suda Clinic
City
Tokyo
ZIP/Postal Code
169-0075
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24968790
Citation
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.
Results Reference
derived
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A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
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