A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

AMAG Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia

Treatments: Drug: Iron Sucrose; Drug: Ferumoxytol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114204

AMAG-FER-IDA-302

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).

Enrollment: 605 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. Participants with IDA defined as having:

   1. Hemoglobin <10.0 g/deciliter (dL)
   2. Transferrin saturation (TSAT) <20%

3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used

4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to two or more classes of drugs
3. Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute(min)/1.73 square meter (m^2)
4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin >600 nanogram/mL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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605 participants in 2 patient groups

Ferumoxytol

Experimental group

Description:

Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters \[mL\]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).

Treatment:

Drug: Ferumoxytol

Iron Sucrose

Active Comparator group

Description:

Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.

Treatment:

Drug: Iron Sucrose