Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02731534

Enrollment

238

Registered

2016-04-07

Start date

2016-05-31

Completion date

2018-01-31

Last updated

2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Brief 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)

Interventions

DRUGZ-213

The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)

DRUGSaccharated Ferric Oxide

The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Inclusion criteria

* Patients with iron deficiency anemia

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Maximum change in Hb value	12 weeks

Secondary

Measure	Time frame
Proportion of responders	12 weeks
Proportion of subjects with normalization in Hb value	12 weeks
Proportion of cumulative dosage	12 weeks
Change in Hb value	12 weeks
Incidence of Adverse Events	12 weeks
Incidence of Adverse Drug Reactions	12 weeks
Dosing period and the number of doses	12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026