Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zeria Pharmaceutical
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated

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