Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02731534
• Date of registration: 03/04/2016
• Prospective Registration: Yes
• Primary sponsor: Zeria Pharmaceutical
• Public title: Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
• Scientific title: Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia
• Date of first enrolment: May 2016
• Target sample size: 238
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02731534
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 49 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Iron Deficiency Anemia

Intervention(s)

Drug: Saccharated Ferric Oxide

Drug: Z-213

Primary Outcome(s)

Maximum change in Hb value [Time Frame: 12 weeks]

Secondary Outcome(s)

Change in Hb value [Time Frame: 12 weeks]

Proportion of subjects with normalization in Hb value [Time Frame: 12 weeks]

Proportion of responders [Time Frame: 12 weeks]

Dosing period and the number of doses [Time Frame: 12 weeks]

Incidence of Adverse Drug Reactions [Time Frame: 12 weeks]

Incidence of Adverse Events [Time Frame: 12 weeks]

Proportion of cumulative dosage [Time Frame: 12 weeks]

Secondary ID(s)

Z213-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors