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A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

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ClinicalTrials.gov Identifier: NCT01114204
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Iron Deficiency Anemia
Interventions: Drug: Ferumoxytol
Drug: Iron Sucrose

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was open to enrollment for adult participants with iron deficiency anemia (IDA), defined as hemoglobin <10.0 grams (g)/deciliter (dL) and transferrin saturation (TSAT) <20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ferumoxytol Participants received a total of 2 doses of intravenous (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 g.
Iron Sucrose 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.

Participant Flow:   Overall Study
    Ferumoxytol   Iron Sucrose
STARTED   406   199 
Received at Least 1 Dose of Study Drug   406   199 
COMPLETED [1]   385   191 
NOT COMPLETED   21   8 
Adverse Event                3                2 
Lost to Follow-up                1                0 
Withdrawal by Subject                10                6 
Death                1                0 
Other-Personal reasons                2                0 
Other-Medical monitor request                1                0 
Other-Participant request                2                0 
Other-Protocol Violation                1                0 
[1] Completed is defined as had study drug and Week 5 visit.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.

Reporting Groups
  Description
Ferumoxytol Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 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 g.
Iron Sucrose 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.
Total Total of all reporting groups

Baseline Measures
   Ferumoxytol   Iron Sucrose   Total 
Overall Participants Analyzed 
[Units: Participants]
 406   199   605 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.0  (14.89)   48.9  (14.66)   48.2  (14.81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      342  84.2%      160  80.4%      502  83.0% 
Male      64  15.8%      39  19.6%      103  17.0% 


  Outcome Measures

1.  Primary:   Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5   [ Time Frame: Baseline (Day 1) through Week 5 ]

2.  Secondary:   Mean Change In Hemoglobin From Baseline To Week 5   [ Time Frame: Baseline (Day 1), Week 5 ]

3.  Secondary:   Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5   [ Time Frame: Baseline (Day 1) through Week 5 ]

4.  Secondary:   Mean Change In TSAT From Baseline To Week 5   [ Time Frame: Baseline (Day 1), Week 5 ]

5.  Secondary:   Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5   [ Time Frame: Baseline (Day 1), Week 5 ]

6.  Secondary:   Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline   [ Time Frame: From Baseline (Day 1) up to Week 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Information
Organization: AMAG Pharmaceuticals, Inc.
phone: 1-877-411-2510
e-mail: amag@druginfo.com


Publications:

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01114204     History of Changes
Other Study ID Numbers: AMAG-FER-IDA-302
First Submitted: April 29, 2010
First Posted: May 3, 2010
Results First Submitted: March 26, 2018
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018