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

AMAG Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia

Treatments: Drug: Ferumoxytol; Drug: FCM

Study type: Interventional

Funder types: Industry

Identifiers

NCT02694978

AMAG-FER-IDA-304

Details and patient eligibility

About

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

Enrollment: 2,014 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,014 participants in 2 patient groups

Ferumoxytol

Experimental group

Description:

Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.

Treatment:

Drug: Ferumoxytol

FCM

Active Comparator group

Description:

Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.

Treatment:

Drug: FCM