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
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