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Completed

NCT Number: NCT02694978

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Trial Site, Sault Ste. Marie, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria include:

  • Participants with IDA and in whom IV iron treatment is indicated and defined as:
  • Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
  • Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
  • Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
  • All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

  • Known hypersensitivity reaction to any component of ferumoxytol or FCM
  • History of allergy to an IV iron
  • History of multiple drug allergies
  • Participants with dialysis-dependent chronic kidney disease
  • Hemoglobin ≤7.0 g/dL
  • Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)

Treatment and study plan

ferumoxytol

Drug

Other names: Feraheme

FCM

Drug

Other names: Injectafer, Ferinject

Primary outcomes

  1. Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension

    Time frame: Day 1 (after first dosing) through Week 5

    All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure.

    Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Secondary outcomes

  1. Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death

    Time frame: Day 1 (after first dosing) through Week 5

    All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC).

    A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  2. Mean Change In Hemoglobin From Baseline To Week 5

    Time frame: Baseline (Day 1), Week 5

    Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.

  3. Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5

    Time frame: Baseline (Day 1), Week 5

    Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.

Sponsors and collaborators

Lead sponsor

AMAG Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2016
Registry last updated
Jul 25, 2023

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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