Clinical trial NCT01039428: A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia
Chronic Kidney Disease
Keywords: hyperphosphatemia
hemodialysis
chitosan
Lead sponsor: KDL Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
timeFrame: baseline and end of the chewing treatment during three week treatment period
Secondary outcomes:
measure: Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL
timeFrame: baseline and end of the treatment
measure: Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3
timeFrame: week 3
measure: Serum Inorganic Phosphorus Level
timeFrame: week 3
measure: Salivary Inorganic Phosphorus Level
timeFrame: week 3
measure: 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])
timeFrame: week 3
measure: Ca×P
timeFrame: week 3
measure: Serum Intact Parathyroid Hormone (PTH) Level
timeFrame: week 3
measure: Serum Intact Fibroblast Growth Factor (FGF) 23 Level
timeFrame: week 3
Other outcomes:
Locations:
city: Toyohashi
country: Japan
facility: Meiyo Clinic
state: Aichi
city: Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Koga
country: Japan
facility: Japanese Red Cross Koga Hospital
state: Ibaragi
city: Mito
country: Japan
facility: Sumiyoshi Clinic Hospital
state: Ibaragi
city: Toride
country: Japan
facility: Toride Medical Center
state: Ibaragi
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaragi
city: Suda
country: Japan
facility: Japanese Red Cross Suwa Hospital
state: Nagano
city: Ueda
country: Japan
facility: Maruko General Hospital
state: Nagano
city: Tokyo
country: Japan
facility: Komagome Kyouritsu Clinic
city: Tokyo
country: Japan
facility: Asagaya Suzuki Clinic
city: Tokyo
country: Japan
facility: Suda Clinic
Study officials:
affiliation: Divison of Nephrology, Department of Medicine, Showa University School of Medicine
name: Tadao Akizawa, MD
role: STUDY_CHAIR
affiliation: Divison of Nephrology and Metabolism, Tokai University School of Medicine
name: Masafumi Fukagawa, MD, PhD
role: STUDY_DIRECTOR
References:
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.