Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia
1 other identifier
interventional
238
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 6, 2018
January 1, 2017
10 months
April 3, 2016
March 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum change in Hb value
12 weeks
Secondary Outcomes (7)
Change in Hb value
12 weeks
Proportion of responders
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
- +2 more secondary outcomes
Study Arms (2)
Z-213
EXPERIMENTALSaccharated Ferric Oxide
ACTIVE COMPARATORInterventions
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)
The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week
Eligibility Criteria
You may qualify if:
- Patients with iron deficiency anemia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2016
First Posted
April 7, 2016
Study Start
May 1, 2016
Primary Completion
March 1, 2017
Study Completion
January 1, 2018
Last Updated
March 6, 2018
Record last verified: 2017-01