Iron Deficiency AnemiaPhase 3NCT02731534
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
A Phase 3 study testing Z-213 and Saccharated Ferric Oxide in people with Iron Deficiency Anemia, run by Zeria Pharmaceutical at 1 site in Japan.
Trial summary
The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA) Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Z-213 and Saccharated Ferric Oxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteJapan
- Study dates
- May 2016to Jan 2018
- Phase
- Phase 3
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with 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 Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
- 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 III Study of Z-213 in Subjects With Iron-deficiency Anemia
The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)
- Conditions
- Iron Deficiency Anemia
- Being tested
- Z-213, Saccharated Ferric Oxide
- 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
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)
Saccharated Ferric OxideDrug
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week
| Study group | Role | What they receive |
|---|---|---|
| Z-213 | Experimental | Not described Receives: Drug: Z-213 |
| Saccharated Ferric Oxide | Active comparator | Not described Receives: Drug: Saccharated Ferric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change in Hb value
Measured: 12 weeks
Secondary outcomes (7)
Change in Hb value
Measured: 12 weeks
Proportion of responders
Measured: 12 weeks
Proportion of subjects with normalization in Hb value
Measured: 12 weeks
Proportion of cumulative dosage
Measured: 12 weeks
Dosing period and the number of doses
Measured: 12 weeks
Incidence of Adverse Events
Measured: 12 weeks
Incidence of Adverse Drug Reactions
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionJan 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731534
- Sponsor's protocol ID
- Z213-02
- Status last verified
- Jan 2017
- First submitted
- 3 Apr 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia
- ClinicalTrials.gov ID
- NCT02731534
- Acronym / sponsor ID
- Z213-02
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Apr 2016 (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 confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-213 | Experimental | Drug: Z-213 |
| Saccharated Ferric Oxide | Active comparator | Drug: Saccharated Ferric Oxide |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with 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 Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
- 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-213The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed) | Drug | Z-213 |
| Saccharated Ferric OxideThe total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week | Drug | Saccharated Ferric Oxide |
Primary outcome
Maximum change in Hb value
Time frame: 12 weeks
7 secondary outcomes
Change in Hb value
Time frame: 12 weeks
Proportion of responders
Time frame: 12 weeks
Proportion of subjects with normalization in Hb value
Time frame: 12 weeks
Proportion of cumulative dosage
Time frame: 12 weeks
Dosing period and the number of doses
Time frame: 12 weeks
Incidence of Adverse Events
Time frame: 12 weeks
Incidence of Adverse Drug Reactions
Time frame: 12 weeks
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 6 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Z-213 and Saccharated Ferric Oxide 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 6 Mar 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Maximum change in Hb value (time frame: 12 weeks). 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 6 Mar 2018.