Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia

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)

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: Z-213; Drug: Saccharated Ferric Oxide

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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)
Active Comparator: Saccharated Ferric Oxide	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum change in Hb value	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of responders	12 weeks
Change in Hb value	12 weeks
Proportion of subjects with normalization in Hb value	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

Collaborators and Investigators

• Sponsor: Zeria Pharmaceutical

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: April 3, 2016
• First Submitted That Met QC Criteria: April 3, 2016
• First Posted (Estimate): April 7, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 4, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: Z213-02