Anemia in Chronic Kidney DiseasePhase 1NCT01978587
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
A Phase 1 study testing JTZ-951 in people with Anemia in Chronic Kidney Disease, run by Shionogi Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia in Chronic Kidney Disease
- What is being tested?
- JTZ-951
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
- Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
Who cannot join
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
- Uncontrolled hypertension at the Screening Visit or Day -1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
- Conditions
- Anemia in Chronic Kidney Disease
- Being tested
- JTZ-951
- Keywords
- End-stage Renal Disease, Hemodialysis, Pharmacokinetics
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTZ-951Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTZ-951 | Experimental | Tablets, 1 dose on Day 1 before hemodialysis Receives: Drug: JTZ-951 |
| Dose 2 JTZ-951 | Experimental | Tablets, 1 dose on Day 8 after hemodialysis Receives: Drug: JTZ-951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
Measured: Days 1 to 4 and 8 to 11
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
Measured: Days 1 to 4 and 8 to 11
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
Measured: Days 1 to 4 and 8 to 11
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
Measured: Days 1 to 4 and 8 to 11
Secondary outcomes (2)
Number of subjects with adverse events
Measured: 14 days
Vital signs and ECG (electrocardiogram)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideyuki Yamamoto, Study chair, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978587
- Sponsor's protocol ID
- AZ951-U-13-005
- Status last verified
- Mar 2014
- First submitted
- 1 Nov 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT01978587
- Acronym / sponsor ID
- AZ951-U-13-005
- Conditions
- Anemia in Chronic Kidney Disease
- Keywords
- End-stage Renal Disease, Hemodialysis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Nov 2013 (estimated)
- 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.
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTZ-951 | Experimental | Drug: JTZ-951Tablets, 1 dose on Day 1 before hemodialysis |
| Dose 2 JTZ-951 | Experimental | Drug: JTZ-951Tablets, 1 dose on Day 8 after hemodialysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
- Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
Key exclusion criteria (2 listed)
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
- Uncontrolled hypertension at the Screening Visit or Day -1
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 |
|---|---|---|
| JTZ-951 | Drug | Dose 1 JTZ-951, Dose 2 JTZ-951 |
Primary outcome
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
Time frame: Days 1 to 4 and 8 to 11
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
Time frame: Days 1 to 4 and 8 to 11
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
Time frame: Days 1 to 4 and 8 to 11
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
Time frame: Days 1 to 4 and 8 to 11
2 secondary outcomes
Number of subjects with adverse events
Time frame: 14 days
Vital signs and ECG (electrocardiogram)
Time frame: 14 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 18 Mar 2014.
Related trials for Anemia in Chronic Kidney Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingPhase 1
Study of CTX001 in Adults With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease
Chronic Kidney Disease, Anemia
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingObservational study
Nutritional Status in Patients With Chronic Kidney Disease Receiving 7.2% Amino Acids During Hemodialysis
Malnutitrion, Chronic Kidney Disease on Hemodialysis
Active, not recruitingPhase 3
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Chronic Kidney Disease, Renal Anemia
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.
Hideyuki Yamamoto study chair
Shionogi Inc.
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 JTZ-951 in people with Anemia in Chronic Kidney Disease, run by Shionogi Inc. at 1 site in United States.
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 2 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 18 Mar 2014. 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 United States. 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?
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis (time frame: Days 1 to 4 and 8 to 11). The study lists 4 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 18 Mar 2014.