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Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Z-213

Saccharated Ferric Oxide

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Z-213

Saccharated Ferric Oxide

Arm Description

Outcomes

Primary Outcome Measures

Maximum change in Hb value

Secondary Outcome Measures

Change in Hb value

Proportion of responders

Proportion of subjects with normalization in Hb value

Proportion of cumulative dosage

Dosing period and the number of doses

Incidence of Adverse Events

Incidence of Adverse Drug Reactions

Full Information

NCT ID

NCT02731534

First Posted

April 3, 2016

Last Updated

March 4, 2018

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02731534

Brief Title

Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Z-213

Arm Type

Experimental

Arm Title

Saccharated Ferric Oxide

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Z-213

Intervention Description

The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)

Intervention Type

Drug

Intervention Name(s)

Saccharated Ferric Oxide

Intervention Description

The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week

Primary Outcome Measure Information:

Title

Maximum change in Hb value

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Hb value

Time Frame

12 weeks

Title

Proportion of responders

Time Frame

12 weeks

Title

Proportion of subjects with normalization in Hb value

Time Frame

12 weeks

Title

Proportion of cumulative dosage

Time Frame

12 weeks

Title

Dosing period and the number of doses

Time Frame

12 weeks

Title

Incidence of Adverse Events

Time Frame

12 weeks

Title

Incidence of Adverse Drug Reactions

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

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