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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694978
• Other study ID #: AMAG-FER-IDA-304
• Status: Completed
• Phase: Phase 3
• Start date: February 29, 2016
• Est. completion date: July 17, 2017

Study information

• Verified date: July 2023
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2014
• Est. completion date: July 17, 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferumoxytol

• FCM

Locations

Country	Name	City	State
Canada	Clinical Trial Site	Montréal	Quebec
Canada	Clinical Trial Site	Sault Ste. Marie	Ontario
Canada	Clinical Trial Site	Vaughan	Ontario
Hungary	Clinical Trial Site	Budapest
Hungary	Clinical Trial Site	Debrecen
Hungary	Clinical Trial Site	Komárom
Hungary	Clinical Trial Site	Szekszárd
Hungary	Clinical Trial Site	Vác
Latvia	Clinical Trial Site	Jelgava
Latvia	Clinical Trial Site	Kraslava
Latvia	Clinical Trial Site	Liepaja
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Ventspils
Lithuania	Clinical Trial Site	Šiauliai
Lithuania	Clinical Trial Site	Kaunas
Lithuania	Clinical Trial Site	Kaunas
Lithuania	Clinical Trial Site	Kaunas
Lithuania	Clinical Trial Site	Klaipeda
Lithuania	Clinical Trial Site	Utena
Lithuania	Clinical Trial Site	Vilnius
Poland	Clinical Trial Site	Bialystok
Poland	Clinical Trial Site	Bialystok
Poland	Clinical Trial Site	Warszawa
Poland	Clinical Trial Site	Wroclaw
Puerto Rico	Clinical Trial Site	Ponce
United States	Clinical Trial Site	Anaheim	California
United States	Clinical Trial Site	Asheville	North Carolina
United States	Clinical Trial Site	Asheville	North Carolina
United States	Clinical Trial Site	Atlanta	Georgia
United States	Clinical Trial Site	Augusta	Georgia
United States	Clinical Trial Site	Austin	Texas
United States	Clinical Trial Site	Baltimore	Maryland
United States	Clinical Trial Site	Bay City	Michigan
United States	Clinical Trial Site	Bethesda	Maryland
United States	Clinical Trial Site	Bristol	Connecticut
United States	Clinical Trial Site	Charlotte	North Carolina
United States	Clinical Trial Site	Chesterfield	Missouri
United States	Clinical Trial Site	Chula Vista	California
United States	Clinical Trial Site	Cincinnati	Ohio
United States	Clinical Trial Site	Cincinnati	Ohio
United States	Clinical Trial Site	Clearwater	Florida
United States	Clinical Trial Site	Corona	California
United States	Clinical Trial Site	Crestview Hills	Kentucky
United States	Clinical Trial Site	East Setauket	New York
United States	Clinical Trial Site	Elk Grove Village	Illinois
United States	Clinical Trial Site	Encino	California
United States	Clinical Trial Site	Evergreen Park	Illinois
United States	Clinical Trial Site	Flint	Michigan
United States	Clinical Trial Site	Flushing	New York
United States	Clinical Trial Site	Fort Sam Houston	Texas
United States	Clinical Trial Site	Fountain Valley	California
United States	Clinical Trial Site	Fredericksburg	Virginia
United States	Clinical Trial Site	Gainesville	Florida
United States	Clinical Trial Site	Germantown	Tennessee
United States	Clinical Trial Site	Granada Hills	California
United States	Clinical Trial Site	Greensboro	North Carolina
United States	Clinical Trial Site	Greenville	South Carolina
United States	Clinical Trial Site	Greenville	South Carolina
United States	Clinical Trial Site	Greer	South Carolina
United States	Clinical Trial Site	Hazel Crest	Illinois
United States	Clinical Trial Site	Hickory	North Carolina
United States	Clinical Trial Site	Houston	Texas
United States	Clinical Trial Site	Houston	Texas
United States	Clinical Trial Site	Houston	Texas
United States	Clinical Trial Site	Huntsville	Alabama
United States	Clinical Trial Site	Jacksonville	North Carolina
United States	Clinical Trial Site	Jenkintown	Pennsylvania
United States	Clinical Trial Site	Kansas City	Missouri
United States	Clinical Trial Site	Kingsport	Tennessee
United States	Clinical Trial Site	Kirksville	Missouri
United States	Clinical Trial Site	La Mesa	California
United States	Clinical Trial Site	Las Vegas	Nevada
United States	Clinical Trial Site	Lauderdale Lakes	Florida
United States	Clinical Trial Site	Lauderdale Lakes	Florida
United States	Clinical Trial Site	Levittown	Pennsylvania
United States	Clinical Trial Site	Longview	Texas
United States	Clinical Trial Site	Marion	Ohio
United States	Clinical Trial Site	Memphis	Tennessee
United States	Clinical Trial Site	Metairie	Louisiana
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami Lakes	Florida
United States	Clinical Trial Site	Morehead City	North Carolina
United States	Clinical Trial Site	New Orleans	Louisiana
United States	Clinical Trial Site	New York	New York
United States	Clinical Trial Site	Norfolk	Virginia
United States	Clinical Trial Site	Norman	Oklahoma
United States	Clinical Trial Site	North Miami	Florida
United States	Clinical Trial Site	Norwalk	Connecticut
United States	Clinical Trial Site	Orange	California
United States	Clinical Trial Site	Orem	Utah
United States	Clinical Trial Site	Oxnard	California
United States	Clinical Trial Site	Raleigh	North Carolina
United States	Clinical Trial Site	Rapid City	South Dakota
United States	Clinical Trial Site	Riverside	California
United States	Clinical Trial Site	Rosedale	New York
United States	Clinical Trial Site	Saginaw	Michigan
United States	Clinical Trial Site	Saginaw	Michigan
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Diego	California
United States	Clinical Trial Site	Savannah	Georgia
United States	Clinical Trial Site	Schertz	Texas
United States	Clinical Trial Site	Scottdale	Pennsylvania
United States	Clinical Trial Site	Seattle	Washington
United States	Clinical Trial Site	Skokie	Illinois
United States	Clinical Trial Site	Skokie	Illinois
United States	Clinical Trial Site	Smithfield	Pennsylvania
United States	Clinical Trial Site	South Miami	Florida
United States	Clinical Trial Site	Thomasville	Georgia
United States	Clinical Trial Site	Tucson	Arizona
United States	Clinical Trial Site	Tucson	Arizona
United States	Clinical Trial Site	Tulsa	Oklahoma
United States	Clinical Trial Site	Tulsa	Oklahoma
United States	Clinical Trial Site	Upland	Pennsylvania
United States	AMAG Pharmaceuticals, Inc.	Waltham	Massachusetts
United States	Clinical Trial Site	West Hollywood	California
United States	Clinical Trial Site	West Palm Beach	Florida
United States	Clinical Trial Site	Westminster	California
United States	Clinical Trial Site	Wichita	Kansas
United States	Clinical Trial Site	Wilmington	North Carolina
United States	Clinical Trial Site	Winston-Salem	North Carolina
United States	Clinical Trial Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AMAG Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Latvia,  Lithuania,  Poland,  Puerto Rico, 

References & Publications (2)

Adkinson NF, Strauss WE, Bernard K, Kaper RF, Macdougall IC, Krop JS. Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions. J Blood Med. 2017 Sep 26;8:155-163. doi: 10.2147/JBM.S142236. eCollection 2017. — View Citation

Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension	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.	Day 1 (after first dosing) through Week 5
Secondary	Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death	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.	Day 1 (after first dosing) through Week 5
Secondary	Mean Change In Hemoglobin From Baseline To 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.	Baseline (Day 1), Week 5
Secondary	Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To 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.	Baseline (Day 1), Week 5