Iron Deficiency Anemia
Conditions
Brief summary
To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia
Interventions
DRUGZ-213
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)
Sponsors
Zeria Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Drug Reactions | 12 weeks |
| Number of participants with Adverse Events | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of responders | 12 weeks |
| Proportion of subjects with normalization in Hb value | 12 weeks |
| Maximum change in Hb value | 12 weeks |
| Number of doses to total dose achieved | 12 weeks |
| Time to total dose achieved | 12 weeks |
| Proportion of cumulative dosage | 12 weeks |
| Change in Hb value | 12 weeks |
Countries
Japan
Outcome results
None listed