Iron Deficiency AnemiaPhase 1NCT02170311
Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia
A Phase 1 study testing Z-213 in people with Iron Deficiency Anemia, run by Zeria Pharmaceutical at 1 site in Japan.
Trial summary
The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Z-213
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2014to Mar 2015
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mild iron deficiency anemia
Who cannot join
- Patients with anemia caused by conditions other than iron deficiency
- Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
- Patients with liver, kidney or circulatory system disease
- Patients with a history or present illness that is a malignant tumor or autoimmune disease
- Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
- Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -"
The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).
- Conditions
- Iron Deficiency Anemia
- Being tested
- Z-213
- Keywords
- Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-213Drug
| Study group | Role | What they receive |
|---|---|---|
| Z-213 100mg | Experimental | Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion. Receives: Drug: Z-213 |
| Z-213 500mg | Experimental | Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion. Receives: Drug: Z-213 |
| Z-213 800mg | Experimental | Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion. Receives: Drug: Z-213 |
| Z-213 1000mg | Experimental | Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion. Receives: Drug: Z-213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).
Measured: 8days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeria Investigator, Study director, Zeria Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170311
- Sponsor's protocol ID
- Z213-01
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2014
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -"
- ClinicalTrials.gov ID
- NCT02170311
- Acronym / sponsor ID
- Z213-01
- Conditions
- Iron Deficiency Anemia
- Keywords
- Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Jun 2014 (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 safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Z-213 100mg | Experimental | Drug: Z-213Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion. |
| Z-213 500mg | Experimental | Drug: Z-213Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion. |
| Z-213 800mg | Experimental | Drug: Z-213Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion. |
| Z-213 1000mg | Experimental | Drug: Z-213Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with mild iron deficiency anemia
Key exclusion criteria (6 listed)
- Patients with anemia caused by conditions other than iron deficiency
- Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
- Patients with liver, kidney or circulatory system disease
- Patients with a history or present illness that is a malignant tumor or autoimmune disease
- Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
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 |
|---|---|---|
| Z-213 | Drug | Z-213 1000mg, Z-213 100mg, Z-213 500mg, Z-213 800mg |
Primary outcome
Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).
Time frame: 8days
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 20 Mar 2015.
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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.
Zeria Investigator study director
Zeria 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 Z-213 in people with Iron Deficiency Anemia, run by Zeria Pharmaceutical 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 1 inclusion and 6 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 20 Mar 2015. 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?
Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae). (time frame: 8days). 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 20 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.