HyperphosphatemiaPhase 2NCT01039428
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
A Phase 2 study testing HS219 in people with Hyperphosphatemia and Chronic Kidney Disease, run by KDL Inc. at 11 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperphosphatemia, Chronic Kidney Disease
- What is being tested?
- HS219
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 11 sitesJapan
- Study dates
- Dec 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Asahi General Hospital
Asahi, Chiba, 289-2511
Japanese Red Cross Koga Hospital
Koga, Ibaragi, 306-0014
Sumiyoshi Clinic Hospital
Mito, Ibaragi, 310-0844
Japanese Red Cross Suwa Hospital
Suda, Nagano, 392-8510
Komagome Kyouritsu Clinic
Tokyo, Tokyo, 113-0021
Asagaya Suzuki Clinic
Tokyo, Tokyo, 166-0004
Suda Clinic
Tokyo, Tokyo, 169-0075
Toride Medical Center
Toride, Ibaragi, 302-0022
Meiyo Clinic
Toyohashi, Aichi-ken, 441-8023
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaragi, 300-0053
Maruko General Hospital
Ueda, Nagano, 386-0493
About this study
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.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- HS219, Placebo
- Keywords
- hyperphosphatemia, hemodialysis, chitosan
- Medical subject headings
- Hyperphosphatemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS219Dietary supplement
Chewing for 30 min three time a day far after meal
PlaceboDietary supplement
Chewing for 30 min three times a day far after meal
| Study group | Role | What they receive |
|---|---|---|
| HS219 | Experimental | Not described Receives: Dietary Supplement: HS219 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
Change in serum inorganic phosphorus at the end of treatment from baseline
Measured: baseline and end of the chewing treatment during three week treatment period
Secondary outcomes (8)
Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL
Measured: baseline and end of the treatment
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- KDL Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadao Akizawa, MD, Study chair, Divison of Nephrology, Department of Medicine, Showa University School of MedicineMasafumi Fukagawa, MD, PhD, Study director, Divison of Nephrology and Metabolism, Tokai University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039428
- Sponsor's protocol ID
- HS219CCR-001
- Status last verified
- May 2012
- First submitted
- 24 Dec 2009
- Last updated
- 14 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 40576086Akizawa 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.
PubMed 24968790
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT01039428
- Acronym / sponsor ID
- HS219CCR-001
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Keywords
- hyperphosphatemia, hemodialysis, chitosan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- KDL Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Posted 1 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS219 | Experimental | Dietary Supplement: HS219 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS219Chewing for 30 min three time a day far after meal | Dietary supplement | HS219 |
| PlaceboChewing for 30 min three times a day far after meal | Dietary supplement | Placebo |
Primary outcome
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
Change in serum inorganic phosphorus at the end of treatment from baseline
8 secondary outcomes
Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL
Time frame: baseline and end of the treatment
Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3
Time frame: week 3
Serum Inorganic Phosphorus Level
Time frame: week 3
Salivary Inorganic Phosphorus Level
Time frame: 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])
Time frame: week 3
Ca×P
Time frame: week 3
Serum Intact Parathyroid Hormone (PTH) Level
Time frame: week 3
Serum Intact Fibroblast Growth Factor (FGF) 23 Level
Time frame: week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 24968790Akizawa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadao Akizawa, MD study chair
Divison of Nephrology, Department of Medicine, Showa University School of Medicine
Masafumi Fukagawa, MD, PhD study director
Divison of Nephrology and Metabolism, Tokai University School of Medicine
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS219 in people with Hyperphosphatemia and Chronic Kidney Disease, run by KDL Inc. at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039428, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2015.