Clinical trial NCT01114139: A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia
Feraheme
ferumoxytol
IDA
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Detailed description: This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of IDA, specifically in adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. The effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (PROs) compared with placebo was evaluated. Investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin \[Hgb\], hematocrit \[Hct\], iron, ferritin, total iron binding capacity \[TIBC\], and transferrin saturation \[TSAT\], and neither the Investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

Eligibility criteria: Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. Participants with IDA defined as having:

   1. Hemoglobin \<10.0 g/deciliter (dL)
   2. Transferrin saturation \<20%
3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
4. 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

Key Exclusion Criteria include:

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

Primary outcomes:
measure: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
timeFrame: Baseline (Day 1) through Week 5
Secondary outcomes:
measure: Mean Change In Hemoglobin From Baseline To Week 5
timeFrame: Baseline (Day 1), Week 5
measure: Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
timeFrame: Baseline (Day 1) through Week 5
measure: Mean Change In TSAT From Baseline To Week 5
timeFrame: Baseline (Day 1), Week 5
measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
timeFrame: Baseline (Day 1), Week 5
measure: Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline
timeFrame: From Baseline (Day 1) up to Week 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Trial Site
state: Alabama
city: Mobile
country: United States
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state: Alabama
city: Montgomery
country: United States
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state: Alabama
city: Montgomery
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state: Alabama
city: Green Valley
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state: Arizona
city: Phoenix
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city: Prince Frederick
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city: Waltham
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facility: AMAG Pharmaceuticals, Inc.
state: Massachusetts
city: Bay City
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state: Michigan
city: Bay City
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city: Saginaw
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country: India
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state: Andhra Pradesh
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country: India
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state: Assam
city: Bangalore
country: India
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state: Karnataka
city: Bangalore
country: India
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state: Karnataka
city: Mangalore
country: India
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country: India
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city: Nagpur
country: India
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country: India
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state: Maharashtra
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country: India
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city: Jaipur
country: India
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state: Rajasthan
city: Chennai
country: India
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state: Tamil Nadu
city: Chennai
country: India
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state: Tamil Nadu
city: Coimbatore
country: India
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state: Tamil Nadu
city: Madurai
country: India
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state: Tamil Nadu
city: Lucknow
country: India
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state: Uttar Pradesh
city: Lucknow
country: India
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state: Uttar Pradesh
city: Daugavpils
country: Latvia
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city: Riga
country: Latvia
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country: Latvia
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city: Riga
country: Latvia
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city: Riga
country: Latvia
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city: Valmiera
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country: Latvia
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city: Ventspils
country: Latvia
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city: Białystok
country: Poland
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city: Sopot
country: Poland
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city: Warszawa
country: Poland
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country: Poland
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city: Wrocław
country: Poland
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city: Zgierz
country: Poland
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Study officials:
References:
citation: Vadhan-Raj S, Strauss W, Ford D, Bernard K, Boccia R, Li J, Allen LF. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014 Jan;89(1):7-12. doi: 10.1002/ajh.23582. Epub 2013 Sep 30.