Chronic Kidney DiseasePhase 1NCT03581071
Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients With Chronic Kidney Disease
A Phase 1 study testing TS-143 in people with Chronic Kidney Disease, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- TS-143
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteJapan
- Study dates
- 6 Oct 2016to 6 Jul 2017
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum concentration of erythropoietin (EPO): <50 mIU/mL at screening test 1, 2, or 3
- Transferrin saturation ≥ 20% or ferritin ≥ 100 ng/mL at screening test 1
- Subjects meeting any of the following criteria
- Subjects who has not used erythropoiesis-stimulating agent (ESA) ≥ eight weeks from screening test 1
- Subjects who has used ESA, other than epoetin beta pegol, ≥ four weeks from screening test 1 and has met all of the following criteria A) to C).
- A)The total ESA dosage for each week could be changed within a range of 50%, compared to the total ESA dosage for one week before screening test 1, for four weeks before screening test 1 B)Acceptable to discontinue ESA the day following screening test 1 to Follow-up 2 C)The fluctuating range of Hb concentration between screening tests 1 and 2 is within ±0.5 g/dL per week (the same criteria applied between screening test 2 and 3)
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- Subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent.
- <Criteria for ND subjects>
- CKD subjects who never received dialysis and do not need to receive dialysis during the study period.
- Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 13.0 g/dL.
- Subjects with an eGFR at screening test 1 ≥ 15 mL/min/1.73m^2 to < 45 mL/min/1.73m^2.
- <Criteria for HD subjects>
- Subjects who received hemodialysis (including diafiltration) three times per week ≥ 12 weeks from acquisition consent.
- Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 12.0 g/dL.
Who cannot join
- Subjects with anemia other than that caused by CKD.
- Subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage
- Subjects with immune disorder with severe inflammation
- Subjects with uncontrolled secondary hyperparathyroidism
- Subjects who already had or will have a kidney transplantation
- Subjects who have a complication which requires treatment such as proliferative retinopathy, macular edema, or macular degeneration. Or, subjects who had a complication which required treatment such as proliferative retinopathy, macular edema, or macular degeneration within 12 months from screening test 1
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- Subjects with congestive heart failure
- Subjects with a medical history of thrombotic disease in the six months from screening test 1
- Subjects with uncontrolled blood pressure; SBP > 170 mmHg or DBP > 100 mmHg at screening test 1 (ESA present, screening tests 1 and 2), (HD subject, evaluated before dialysis)
Trial locations and contacts
1 site in 1 country.
Japan1 site
Taisho Pharmaceutical Co., Ltd selected site
Tokyo and Other Japanese City
About this study
To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.
- Conditions
- Chronic Kidney Disease
- Being tested
- TS-143
- Keywords
- Dialysis, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-143Drug
| Study group | Role | What they receive |
|---|---|---|
| Step1:1mg in non-dialysis subject | Experimental | Not described Receives: Drug: TS-143 |
| Step2-1:1mg in hemodialysis subjects | Experimental | Not described Receives: Drug: TS-143 |
| Step2-2:6mg in non-dialysis subject | Experimental | Not described Receives: Drug: TS-143 |
| Step3-1:11㎎ in hemodialysis subjects | Experimental | Not described Receives: Drug: TS-143 |
| Step3-2:11㎎ in non-dialysis subject | Experimental | Not described Receives: Drug: TS-143 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To evaluate the safety of TS-143 given single administration in CKD patients by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Measured: 8 days
Plasma concentrations of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Measured: 7 days
Urinary excretions of unchanged form (ng/mL)
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Measured: 24 hours
Serum EPO concentration
Measured: 4 days
Reticulocyte count
Measured: 7 days
Plasma vascular endothelial growth factor (VEGF) concentration
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start6 Oct 2016
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Okuyama, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581071
- Sponsor's protocol ID
- TS143-01-02
- Other IDs
- JapicCTI-163383
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2018
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.
PubMed 30176654
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
- Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03581071
- Acronym / sponsor ID
- TS143-01-02
- Conditions
- Chronic Kidney Disease
- Keywords
- Dialysis, CKD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 10 Jul 2018 (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.
To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Step1:1mg in non-dialysis subject | Experimental | Drug: TS-143 |
| Step2-1:1mg in hemodialysis subjects | Experimental | Drug: TS-143 |
| Step2-2:6mg in non-dialysis subject | Experimental | Drug: TS-143 |
| Step3-1:11㎎ in hemodialysis subjects | Experimental | Drug: TS-143 |
| Step3-2:11㎎ in non-dialysis subject | Experimental | Drug: TS-143 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Serum concentration of erythropoietin (EPO): <50 mIU/mL at screening test 1, 2, or 3
- Transferrin saturation ≥ 20% or ferritin ≥ 100 ng/mL at screening test 1
- Subjects meeting any of the following criteria
- A)The total ESA dosage for each week could be changed within a range of 50%, compared to the total ESA dosage for one week before screening test 1, for four weeks before screening test 1 B)Acceptable to discontinue ESA the day following screening test 1 to Follow-up 2 C)The fluctuating range of Hb concentration between screening tests 1 and 2 is within ±0.5 g/dL per week (the same criteria applied between screening test 2 and 3)
- Subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent.
Key exclusion criteria (9 listed)
- Subjects with anemia other than that caused by CKD.
- Subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage
- Subjects with immune disorder with severe inflammation
- Subjects with uncontrolled secondary hyperparathyroidism
- Subjects who already had or will have a kidney transplantation
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-143 | Drug | Step1:1mg in non-dialysis subject, Step2-1:1mg in hemodialysis subjects, Step2-2:6mg in non-dialysis subject, Step3-1:11㎎ in hemodialysis subjects, Step3-2:11㎎ in non-dialysis subject |
Primary outcome
Incidence of adverse events
Time frame: 8 days
To evaluate the safety of TS-143 given single administration in CKD patients by incidence of adverse events which include abnormal electrocardiograms, vital signs, and clinical laboratory parameters.
Plasma concentrations of unchanged form (ng/mL)
Time frame: 7 days
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) were calculated by dose group and evaluation timing.
Urinary excretions of unchanged form (ng/mL)
Time frame: 24 hours
The descriptive statistics (e.g., number of subjects, arithmetic mean, standard deviation) for the total urinary excretion (amount and fraction) were summarized by dose group.
Serum EPO concentration
Time frame: 4 days
Reticulocyte count
Time frame: 7 days
Plasma vascular endothelial growth factor (VEGF) concentration
Time frame: 4 days
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.
- Results publication: PubMed 30176654Shinfuku A, Shimazaki T, Fujiwara M, Sato F, Watase H, Numazaki T, Kawakita Y, Mutoh M, Yamasaki H, Takayama N, Kato S, Sugimoto T, Maruyama J. Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers. Am J Nephrol. 2018;48(3):157-164. doi: 10.1159/000492181. Epub 2018 Sep 3.
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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.
Shigeru Okuyama 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-143 in people with Chronic Kidney Disease, 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 14 inclusion and 9 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. 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?
Incidence of adverse events (time frame: 8 days). The study lists 6 primary outcomes in all. 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 NCT03581071, which also lists 1 linked publication.
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.