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

AMAG Pharmaceuticals, Inc.162 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

162

Conditions

Iron Deficiency Anemia Kidney Disease

Interventions

FerumoxytolDRUG

IV Ferumoxytol

Iron SucroseDRUG

IV Iron Sucrose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (36)

Outcomes

Primary Outcomes

Mean Change In Hemoglobin From Baseline (Day 1) To 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.

Time frame: Baseline (Day 1), Week 5

Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) 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).

Time frame: Baseline (Day 1) and up to Week 5

Data from ClinicalTrials.gov

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