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

To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Z-213

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Z-213	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Drug Reactions	12 weeks
Number of participants with Adverse Events	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of responders	12 weeks
Maximum change in Hb value	12 weeks
Change in Hb value	12 weeks
Proportion of subjects with normalization in Hb value	12 weeks
Proportion of cumulative dosage	12 weeks
Number of doses to total dose achieved	12 weeks
Time to total dose achieved	12 weeks

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 4, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: Z213-03