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Completed

NCT Number: NCT02731534

Efficacy Study of Intravenous Iron Preparation to 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)

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Z-213

Drug

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

Saccharated Ferric Oxide

Drug

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

Primary outcomes

  1. Maximum change in Hb value

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Hb value

    Time frame: 12 weeks

  2. Proportion of responders

    Time frame: 12 weeks

  3. Proportion of subjects with normalization in Hb value

    Time frame: 12 weeks

  4. Proportion of cumulative dosage

    Time frame: 12 weeks

  5. Dosing period and the number of doses

    Time frame: 12 weeks

  6. Incidence of Adverse Events

    Time frame: 12 weeks

  7. Incidence of Adverse Drug Reactions

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Apr 7, 2016
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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