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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z-213 | Experimental |
| |
| Saccharated Ferric Oxide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-213 | Drug | The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum change in Hb value | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb value | 12 weeks | |
| Proportion of responders | 12 weeks | |
| Proportion of subjects with normalization in Hb value |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Saccharated Ferric Oxide | Drug | The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week |
|
| 12 weeks |
| Proportion of cumulative dosage | 12 weeks |
| Dosing period and the number of doses | 12 weeks |
| Incidence of Adverse Events | 12 weeks |
| Incidence of Adverse Drug Reactions | 12 weeks |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |