Hyperphosphatemia Patients on HemodialysisPhase 3NCT07548840
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
A Phase 3 study testing TS-172 20~60 mg/day in people with Hyperphosphatemia Patients on Hemodialysis, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on hemodialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia Patients on Hemodialysis
- What is being tested?
- TS-172 20~60 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteJapan
- Study dates
- 8 May 2026to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week at least 12 weeks prior to Visit 1 (Week -4)
- Patients aged >= 18 years at the time of obtaining informed consent
- Patients who are receiving at least one phosphate-lowering agent (phosphate binder and tenapanor hydrochloride) within approved dosage, and whose dosing regimen for all phosphate-lowering agents has been unchanged during the last 4 weeks prior to Visit 1 (Week -4).
- Patients with serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL at Visit 1 (Week -4)
- Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is >= 5.5 mg/dL and < 10.0 mg/dL.
Who cannot join
- Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
- Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
- Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on hemodialysis
- Being tested
- TS-172 20~60 mg/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-172 20~60 mg/dayDrug
oral administration of TS-172 20~60 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 'TS-172 20~60 mg/day | Experimental | Not described Receives: Drug: TS-172 20~60 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement rate of the target serum phosphorus level
Measured: Week 8
Secondary outcomes (3)
Change from baseline in serum concentration of phosphorus
Measured: Up to Week 8
Concentration of corrected serum calcium
Measured: Up to Week 8
Serum Ca × P product
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start8 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperphosphatemia Patients on HemodialysisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548840
- Sponsor's protocol ID
- TS172-03-11
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT07548840
- Acronym / sponsor ID
- TS172-03-11
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, single-arm clinical study of TS-172 in hyperphosphatemia patients on hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'TS-172 20~60 mg/day | Experimental | Drug: TS-172 20~60 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week at least 12 weeks prior to Visit 1 (Week -4)
- Patients aged >= 18 years at the time of obtaining informed consent
- Patients who are receiving at least one phosphate-lowering agent (phosphate binder and tenapanor hydrochloride) within approved dosage, and whose dosing regimen for all phosphate-lowering agents has been unchanged during the last 4 weeks prior to Visit 1 (Week -4).
- Patients with serum phosphorus concentration of >= 3.5 mg/dL and < 5.5 mg/dL at Visit 1 (Week -4)
- Patients whose serum phosphorus concentration at Visit 3 (Week -2) or Visit 4 (Week -1) has increased by at least 1.0 mg/dL compared with the value at Visit 1 (Week -4) and is >= 5.5 mg/dL and < 10.0 mg/dL.
Key exclusion criteria (3 listed)
- Patients with confirmed serum intact PTH concentration >500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
- Patients with serum phosphorus concentration >= 10.0 mg/dL from Visit 2 (Week -3) to Visit 4 (Week -1)
- Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
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 |
|---|---|---|
| TS-172 20~60 mg/dayoral administration of TS-172 20~60 mg/day | Drug | 'TS-172 20~60 mg/day |
Primary outcome
Achievement rate of the target serum phosphorus level
Time frame: Week 8
3 secondary outcomes
Change from baseline in serum concentration of phosphorus
Time frame: Up to Week 8
Concentration of corrected serum calcium
Time frame: Up to Week 8
Serum Ca × P product
Time frame: Up to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hyperphosphatemia Patients on Hemodialysis
Not yet recruitingObservational study
Tenapanor in Maintenance Hemodialysis Patients
Hyperphosphatemia, Maintenance Hemodialysis
RecruitingPhase 3
A Phase 3 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
Hyperphosphatemia Patients on Hemodialysis
RecruitingPhase 3
A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Hyperphosphatemia Patients on Hemodialysis
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.
Taisho Director study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TS-172 20~60 mg/day in people with Hyperphosphatemia Patients on Hemodialysis, run by Taisho Pharmaceutical Co., Ltd. at 1 site 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Achievement rate of the target serum phosphorus level (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.