Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Enrollment
- 162
- Locations
- 2
- Primary Endpoint
- Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Key Inclusion Criteria include:
- •Males and females ≥18 years of age
- •An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
- •Hemoglobin <11.0 g/deciliter (dL)
- •Transferrin saturation <30%
- •Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
- •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:
- •History of allergy to IV iron
- •Allergy to 2 or more classes of drugs
- •Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
- •Hemoglobin ≤7.0 g/dL
- •Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
- •Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)
Arms & Interventions
Ferumoxytol
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).
Intervention: Ferumoxytol (Drug)
Iron Sucrose
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.
Intervention: Iron Sucrose (Drug)
Outcomes
Primary Outcomes
Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
Time Frame: Baseline (Day 1), Week 5
The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline) The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
Time Frame: Baseline (Day 1) and up to Week 5
The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).
Secondary Outcomes
No secondary outcomes reported