A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
NCT ID: NCT01039428
Last Updated: 2015-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2009-12-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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HS219
HS219
Chewing for 30 min three time a day far after meal
Placebo
Placebo
Chewing for 30 min three times a day far after meal
Interventions
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HS219
Chewing for 30 min three time a day far after meal
Placebo
Chewing for 30 min three times a day far after meal
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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KDL Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tadao Akizawa, MD
Role: STUDY_CHAIR
Divison of Nephrology, Department of Medicine, Showa University School of Medicine
Masafumi Fukagawa, MD, PhD
Role: STUDY_DIRECTOR
Divison of Nephrology and Metabolism, Tokai University School of Medicine
Locations
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Meiyo Clinic
Toyohashi, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
Japanese Red Cross Koga Hospital
Koga, Ibaragi, Japan
Sumiyoshi Clinic Hospital
Mito, Ibaragi, Japan
Toride Medical Center
Toride, Ibaragi, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaragi, Japan
Japanese Red Cross Suwa Hospital
Suda, Nagano, Japan
Maruko General Hospital
Ueda, Nagano, Japan
Komagome Kyouritsu Clinic
Tokyo, Tokyo, Japan
Asagaya Suzuki Clinic
Tokyo, Tokyo, Japan
Suda Clinic
Tokyo, Tokyo, Japan
Countries
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References
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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.
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.
Other Identifiers
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HS219CCR-001
Identifier Type: -
Identifier Source: org_study_id
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