Hyperphosphatemia Patients on HemodialysisPhase 2NCT05699239
A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
A Phase 2 study testing TS-172 10mg bid, TS-172 30mg bid and TS-172 60mg bid in people with Hyperphosphatemia Patients on Hemodialysis, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hyperphosphatemia Patients on Hemodialysis
- What is being tested?
- TS-172 10mg bid, TS-172 30mg bid and TS-172 60mg bid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteJapan
- Study dates
- 8 Feb 2023to 26 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 79 years
- 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 for at least 12 weeks prior to Visit 1 (Week -4)
- Patients aged ≥18 to <80 years at the time of obtaining informed consent
- Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)
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 5 (Week 0)
- Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
- Being tested
- TS-172 10mg bid, TS-172 30mg bid, TS-172 60mg bid, TS-172 20mg tid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-172 10mg bidDrug
oral administration of TS-172 10 mg bid
TS-172 30mg bidDrug
oral administration of TS-172 30 mg bid
TS-172 60mg bidDrug
oral administration of TS-172 60 mg bid
TS-172 20mg tidDrug
oral administration of TS-172 20 mg tid
PlaceboDrug
oral administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| 10 mg bid | Experimental | Patients receive TS-172 10 mg bid. Receives: Drug: TS-172 10mg bid |
| 30 mg bid | Experimental | Patients receive TS-172 30 mg bid. Receives: Drug: TS-172 30mg bid |
| 60 mg bid | Experimental | Patients receive TS-172 60 mg bid. Receives: Drug: TS-172 60mg bid |
| 20 mg tid | Experimental | Patients receive TS-172 20 mg tid. Receives: Drug: TS-172 20mg tid |
| Placebo | Placebo comparator | Patients receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum concentration of phosphorus
Measured: Week 4
Secondary outcomes (3)
Achievement ratio of patients with the target serum concentration of phosphorus
Measured: Up to Week 4
Concentration of corrected serum calcium
Measured: Up to Week 4
Serum calcium times phosphorus product
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start8 Feb 2023
- Primary completion26 Dec 2023
- Study completion26 Dec 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 326 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
- NCT05699239
- Sponsor's protocol ID
- TS172-02-01
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT05699239
- Acronym / sponsor ID
- TS172-02-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 26 Jan 2023 (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.
A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 10 mg bid | Experimental | Drug: TS-172 10mg bidPatients receive TS-172 10 mg bid. |
| 30 mg bid | Experimental | Drug: TS-172 30mg bidPatients receive TS-172 30 mg bid. |
| 60 mg bid | Experimental | Drug: TS-172 60mg bidPatients receive TS-172 60 mg bid. |
| 20 mg tid | Experimental | Drug: TS-172 20mg tidPatients receive TS-172 20 mg tid. |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive placebo. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
- Patients aged ≥18 to <80 years at the time of obtaining informed consent
- Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)
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 5 (Week 0)
- 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 10mg bidoral administration of TS-172 10 mg bid | Drug | 10 mg bid |
| TS-172 30mg bidoral administration of TS-172 30 mg bid | Drug | 30 mg bid |
| TS-172 60mg bidoral administration of TS-172 60 mg bid | Drug | 60 mg bid |
| TS-172 20mg tidoral administration of TS-172 20 mg tid | Drug | 20 mg tid |
| Placebooral administration of placebo | Drug | Placebo |
Primary outcome
Change from baseline in serum concentration of phosphorus
Time frame: Week 4
3 secondary outcomes
Achievement ratio of patients with the target serum concentration of phosphorus
Time frame: Up to Week 4
Concentration of corrected serum calcium
Time frame: Up to Week 4
Serum calcium times phosphorus product
Time frame: Up to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Hyperphosphatemia Patients on Hemodialysis
Not yet recruitingObservational study
Tenapanor in Maintenance Hemodialysis Patients
Hyperphosphatemia, Maintenance Hemodialysis
Active, not recruitingPhase 3
A Clinical Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Hyperphosphatemia Patients on Hemodialysis
Not yet recruitingObservational study
Real-World Efficacy and Safety of Tenapanor Plus Phosphate Binders in Hemodialysis Patients With Hyperphosphatemia
CKD 5D, Hemodialysis, Hyperphosphatemia Undergoing 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 2 study testing TS-172 10mg bid, TS-172 30mg bid and TS-172 60mg bid 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 3 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: finished, as of the sponsor's last update on 28 Feb 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in serum concentration of phosphorus (time frame: Week 4). 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 28 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.