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

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).

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Key information

Conditions

Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Kidney Disease Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ferumoxytol

Drug

IV Ferumoxytol

Other names: Feraheme

Iron sucrose

Drug

IV Iron Sucrose

Other names: Venofer

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).

Sponsors and collaborators

Lead sponsor

AMAG Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: FIRST

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Jan 20, 2010
Registry last updated: Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed