A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (FIRST)

AMAG Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Anemia; Iron Deficiency; Kidney Disease

Treatments: Drug: Ferumoxytol; Drug: Iron Sucrose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01052779

FER-CKD-201

2009-015630-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
3. Hemoglobin <11.0 g/deciliter (dL)
4. Transferrin saturation <30%
5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
6. 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 the study

Exclusion criteria

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to 2 or more classes of drugs
3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
4. Hemoglobin ≤7.0 g/dL
5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Ferumoxytol

Experimental group

Description:

Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

Treatment:

Drug: Ferumoxytol

Iron Sucrose

Active Comparator group

Description:

Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

Treatment:

Drug: Iron Sucrose