Patients on HemodialysisPhase 1NCT06849778
An Open-label Pharmacokinetic Study of TS-172 in Patients on Hemodialysis
A Phase 1 study testing TS-172 in people with Patients on Hemodialysis, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis Read more about this study
- Who is it for?
- Ages 18 to 74 years, men only
- Conditions the study is for
- Patients on Hemodialysis
- What is being tested?
- TS-172
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteJapan
- Study dates
- 22 Mar 2025to 24 Apr 2025
- Phase
- Phase 1
- 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 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to the screening test
- Patients aged >= 18 and < 75 years at the time of obtaining informed consent
Who cannot join
- Patients with gastric or intestinal ulceration or a history of them within the past year prior to the date of initiation of treatment, or patients with inflammatory bowel disease or irritable bowel syndrome, or a history of these within the past 5 years prior to the date of initiation of treatment
- Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
- Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Pharmacokinetic Study of TS-172 in Patients on Hemodialysis
A phase 1, open-label, pharmacokinetic study of TS-172 in patients on hemodialysis
- Conditions
- Patients on Hemodialysis
- Being tested
- TS-172
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-172Drug
oral administration of TS-172 20 mg
| Study group | Role | What they receive |
|---|---|---|
| TS-172 | Experimental | Not described Receives: Drug: TS-172 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of unchanged form in plasma
Measured: Day 1, 2, 8 and 9
Concentration of major metabolites in plasma
Measured: Day 1, 2, 8 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start22 Mar 2025
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT06849778
- Sponsor's protocol ID
- TS172-03-04
- Status last verified
- May 2025
- First submitted
- 16 Feb 2025
- Last updated
- 15 May 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Pharmacokinetic Study of TS-172 in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT06849778
- Acronym / sponsor ID
- TS172-03-04
- Conditions
- Patients on Hemodialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 27 Feb 2025 (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 1, open-label, pharmacokinetic study of TS-172 in 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 | Experimental | Drug: TS-172 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese male patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to the screening test
- Patients aged >= 18 and < 75 years at the time of obtaining informed consent
Key exclusion criteria (3 listed)
- Patients with gastric or intestinal ulceration or a history of them within the past year prior to the date of initiation of treatment, or patients with inflammatory bowel disease or irritable bowel syndrome, or a history of these within the past 5 years prior to the date of initiation of treatment
- Patients scheduled for renal transplantation, home hemodialysis or change of dialysis facility (transfer or temporary dialysis at other hospital) during the study period
- Patients who frequently experience diarrhea (defined as Bristol Stool Scale score of 6 or higher)
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-172oral administration of TS-172 20 mg | Drug | TS-172 |
Primary outcome
Concentration of unchanged form in plasma
Time frame: Day 1, 2, 8 and 9
Concentration of major metabolites in plasma
Time frame: Day 1, 2, 8 and 9
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 15 May 2025.
- Individual participant dataSharing planned: No
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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.
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 1 study testing TS-172 in people with 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 2 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 15 May 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Concentration of unchanged form in plasma (time frame: Day 1, 2, 8 and 9). The study lists 2 primary outcomes in all. 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 15 May 2025.