Anemia of Chronic Kidney DiseasePhase 1NCT01971164
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
A Phase 1 study testing JTZ-951 in people with Anemia of Chronic Kidney Disease, run by Shionogi Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic 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 of Chronic Kidney Disease
- What is being tested?
- JTZ-951
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2013to Jul 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
- Hemoglobin value as defined in the protocol
- Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening Visit as defined in the protocol
Who cannot join
- Transferrin saturation and ferritin levels at the Screening Visit as defined in the protocol
- Anemia due to known causes other than chronic kidney disease
- Known history of hyporesponsiveness to ESAs
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening visit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Lakewood, Colorado
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Orlando, Florida
Study site
Saint Paul, Minnesota
About this study
Official title: Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
- Conditions
- Anemia of Chronic Kidney Disease
- Being tested
- JTZ-951, Placebo
- Keywords
- anemia, chronic kidney disease, hemodialysis
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTZ-951Drug
Subjects will receive JTZ-951 or Placebo
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days Receives: Drug: JTZ-951; Drug: Placebo |
| Dose 2 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days Receives: Drug: JTZ-951; Drug: Placebo |
| Dose 3 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days Receives: Drug: JTZ-951; Drug: Placebo |
| Dose 4 JTZ-951 or Placebo | Experimental | Tablets, 1 dose per day for 15 days Receives: Drug: JTZ-951; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: 15 days
Vital signs and 12 lead ECGs
Measured: 15 days
Cmax (maximum concentration)
Measured: 15 days
tmax (time to reach maximum concentration)
Measured: 15 days
t1/2 (elimination half-life)
Measured: 15 days
AUC (area under the concentration-time curve)
Measured: 15 days
AR (accumulation ratio)
Measured: 15 days
RBC (red blood cell) count
Measured: 15 days
Hgb (hemoglobin)
Measured: 15 days
TSAT (transferrin saturation)
Measured: 15 days
serum ferritin
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionJul 2014
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 Anemia of 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 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
- NCT01971164
- Sponsor's protocol ID
- AZ951-U-12-004
- Status last verified
- Jul 2014
- First submitted
- 15 Oct 2013
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT01971164
- Acronym / sponsor ID
- AZ951-U-12-004
- Conditions
- Anemia of Chronic Kidney Disease
- Keywords
- anemia, chronic kidney disease, hemodialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Oct 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 determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTZ-951 or Placebo | Experimental | Drug: JTZ-951, Drug: PlaceboTablets, 1 dose per day for 15 days |
| Dose 2 JTZ-951 or Placebo | Experimental | Drug: JTZ-951, Drug: PlaceboTablets, 1 dose per day for 15 days |
| Dose 3 JTZ-951 or Placebo | Experimental | Drug: JTZ-951, Drug: PlaceboTablets, 1 dose per day for 15 days |
| Dose 4 JTZ-951 or Placebo | Experimental | Drug: JTZ-951, Drug: PlaceboTablets, 1 dose per day for 15 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
- Hemoglobin value as defined in the protocol
- Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening Visit as defined in the protocol
Key exclusion criteria (4 listed)
- Transferrin saturation and ferritin levels at the Screening Visit as defined in the protocol
- Anemia due to known causes other than chronic kidney disease
- Known history of hyporesponsiveness to ESAs
- Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening visit
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-951Subjects will receive JTZ-951 or Placebo | Drug | Dose 1 JTZ-951 or Placebo, Dose 2 JTZ-951 or Placebo, Dose 3 JTZ-951 or Placebo, Dose 4 JTZ-951 or Placebo |
| Placebo | Drug | Dose 1 JTZ-951 or Placebo, Dose 2 JTZ-951 or Placebo, Dose 3 JTZ-951 or Placebo, Dose 4 JTZ-951 or Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: 15 days
Vital signs and 12 lead ECGs
Time frame: 15 days
Cmax (maximum concentration)
Time frame: 15 days
tmax (time to reach maximum concentration)
Time frame: 15 days
t1/2 (elimination half-life)
Time frame: 15 days
AUC (area under the concentration-time curve)
Time frame: 15 days
AR (accumulation ratio)
Time frame: 15 days
RBC (red blood cell) count
Time frame: 15 days
Hgb (hemoglobin)
Time frame: 15 days
TSAT (transferrin saturation)
Time frame: 15 days
serum ferritin
Time frame: 15 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 14 Jul 2014.
- Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
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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.
Hideyuki Yamamoto study chair
Shionogi Inc.
5 sites 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 of Chronic Kidney Disease, run by Shionogi Inc. at 5 sites 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 4 inclusion and 4 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Number of subjects with adverse events (time frame: 15 days). The study lists 11 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 NCT01971164, 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 14 Jul 2014.