Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

Iron Deficiency Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828319
• Other study ID #: Z213-03
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2016
• Last updated: March 4, 2018
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Drug Reactions		12 weeks
Primary	Number of participants with Adverse Events		12 weeks
Secondary	Maximum change in Hb value		12 weeks
Secondary	Change in Hb value		12 weeks
Secondary	Proportion of responders		12 weeks
Secondary	Proportion of subjects with normalization in Hb value		12 weeks
Secondary	Proportion of cumulative dosage		12 weeks
Secondary	Number of doses to total dose achieved		12 weeks
Secondary	Time to total dose achieved		12 weeks