Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

Zeria Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia

Treatments: Drug: Saccharated Ferric Oxide; Drug: Z-213

Study type: Interventional

Funder types: Industry

Identifiers

NCT02731534

Z213-02

Details and patient eligibility

About

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)

Enrollment: 238 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Z-213

Experimental group

Treatment:

Drug: Z-213

Saccharated Ferric Oxide

Active Comparator group

Treatment:

Drug: Saccharated Ferric Oxide