NCT02828319

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

June 23, 2016

Last Update Submit

March 4, 2018

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (2)

  • Number of participants with Adverse Drug Reactions

    12 weeks

  • Number of participants with Adverse Events

    12 weeks

Secondary Outcomes (7)

  • Maximum change in Hb value

    12 weeks

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Z-213

EXPERIMENTAL
Drug: Z-213

Interventions

Z-213DRUG

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

Z-213

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

JP(1)