Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
Phase 3
Completed
- Conditions
- Iron Deficiency Anemia
- Interventions
- Registration Number
- NCT02731534
- Lead Sponsor
- Zeria Pharmaceutical
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 238
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Z-213 Z-213 - Saccharated Ferric Oxide Saccharated Ferric Oxide -
- Primary Outcome Measures
Name Time Method Maximum change in Hb value 12 weeks
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events 12 weeks Incidence of Adverse Drug Reactions 12 weeks Proportion of subjects with normalization in Hb value 12 weeks Change in Hb value 12 weeks Proportion of responders 12 weeks Proportion of cumulative dosage 12 weeks Dosing period and the number of doses 12 weeks