Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

605

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Aug 2010

Geographic Reach

14 countries

96 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

April 29, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2010

Completed

3 months until next milestone

Study Start

First participant enrolled

August 10, 2010

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2011

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2012

Completed

6 years until next milestone

Results Posted

Study results publicly available

June 11, 2018

Completed

Last Updated

April 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

April 29, 2010

Results QC Date

March 26, 2018

Last Update Submit

March 31, 2022

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemiaFerahemeferumoxytoliron sucroseVenoferIDA

Outcome Measures

Primary Outcomes (1)

Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
Baseline (Day 1) through Week 5

Secondary Outcomes (5)

Mean Change In Hemoglobin From Baseline To Week 5
Baseline (Day 1), Week 5
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Baseline (Day 1) through Week 5
Mean Change In TSAT From Baseline To Week 5
Baseline (Day 1), Week 5
Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
Baseline (Day 1), Week 5
Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline
From Baseline (Day 1) up to Week 5

Study Arms (2)

Ferumoxytol

EXPERIMENTAL

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).

Drug: Ferumoxytol

Iron Sucrose

ACTIVE COMPARATOR

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.

Drug: Iron Sucrose

Interventions

FerumoxytolDRUG

IV Ferumoxytol

Also known as: Feraheme

Ferumoxytol

Iron SucroseDRUG

IV Iron Sucrose

Also known as: Venofer

Iron Sucrose

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females ≥18 years of age
Participants with IDA defined as having:
Hemoglobin \<10.0 g/deciliter (dL)
Transferrin saturation (TSAT) \<20%
Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
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

You may not qualify if:

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

Contact the study team to confirm eligibility.