Trials / Completed
CompletedNCT02731534
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- Zeria Pharmaceutical · Industry
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Z-213 | The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed) |
| DRUG | Saccharated Ferric Oxide | The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2017-03-01
- Completion
- 2018-01-01
- First posted
- 2016-04-07
- Last updated
- 2018-03-06
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02731534. Inclusion in this directory is not an endorsement.