Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS219 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS219 | Dietary Supplement | Chewing for 30 min three time a day far after meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL | baseline and end of the treatment | |
| Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3 | week 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tadao Akizawa, MD | Divison of Nephrology, Department of Medicine, Showa University School of Medicine | Study Chair |
| Masafumi Fukagawa, MD, PhD | Divison of Nephrology and Metabolism, Tokai University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meiyo Clinic | Toyohashi | Aichi-ken | 441-8023 | Japan | ||
| Asahi General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | 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. | |
| 24968790 | Derived | 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. |
Not provided
Not provided
Sixty eight HD patients maintained on calcium carbonate (33 subjects) or sevelamer (35 subjects) were enrolled during January - April, 2010. Sixty-three patients chewed at least one gum: 35 HS219 and 28 placebo.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HS219 | Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks. |
| FG001 | Placebo | Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HS219 | Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks. |
| BG001 | Placebo | Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | baseline and end of the chewing treatment during three week treatment period |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HS219 | Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| common cold | Infections and infestations |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | KDL | 818058844243 | toiawase@advance-cro.co.jp |
Not provided
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
Chewing for 30 min three times a day far after meal |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Asahi |
| Chiba |
| 289-2511 |
| Japan |
| Japanese Red Cross Koga Hospital | Koga | Ibaragi | 306-0014 | Japan |
| Sumiyoshi Clinic Hospital | Mito | Ibaragi | 310-0844 | Japan |
| Toride Medical Center | Toride | Ibaragi | 302-0022 | Japan |
| Tsuchiura Kyodo General Hospital | Tsuchiura | Ibaragi | 300-0053 | Japan |
| Japanese Red Cross Suwa Hospital | Suda | Nagano | 392-8510 | Japan |
| Maruko General Hospital | Ueda | Nagano | 386-0493 | Japan |
| Komagome Kyouritsu Clinic | Tokyo | Tokyo | 113-0021 | Japan |
| Asagaya Suzuki Clinic | Tokyo | Tokyo | 166-0004 | Japan |
| Suda Clinic | Tokyo | Tokyo | 169-0075 | Japan |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL | Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Number | participants | baseline and end of the treatment |
|
|
|
| Secondary | Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3 | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Number | participants | week 3 |
|
|
|
| Secondary | Serum Inorganic Phosphorus Level | Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | week 3 |
|
|
|
| Secondary | Salivary Inorganic Phosphorus Level | Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | week 3 |
|
|
|
| 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). | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | week 3 |
|
|
|
| Secondary | Ca×P | Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday). | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | mg/mL*mg/mL | week 3 |
|
|
|
| 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). | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | week 3 |
|
|
|
| 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). | Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Mean | Standard Deviation | log10(pg/mL) | week 3 |
|
|
|
| 0 |
| 35 |
| 6 |
| 35 |
| EG001 | Placebo | Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks. | 0 | 28 | 12 | 28 |
| queasy | Gastrointestinal disorders |
|
Not provided
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |