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A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

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ClinicalTrials.gov Identifier: NCT01114217
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: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Iron Deficiency Anemia
Intervention: Drug: Ferumoxytol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who previously enrolled in and completed AMAG-FER-IDA-301 [NCT01114139], received any dose of study drug, and met the inclusion/exclusion criteria were eligible to enroll in this Extension Study AMAG-FER-IDA-303.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Received Ferumoxytol in IDA-303 Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent iron deficiency anemia (IDA), defined as hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week Treatment Period (TP) and received a total of 2 doses of ferumoxytol 510 milligrams (mg) intravenously (IV). The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 grams (g).
Did Not Receive Ferumoxytol in IDA-303 Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139] and did not receive ferumoxytol during AMAG-FER-IDA-303.

Participant Flow:   Overall Study
    Received Ferumoxytol in IDA-303   Did Not Receive Ferumoxytol in IDA-303
STARTED   337   297 
Received at Least 1 Dose of Ferumoxytol   337   0 
COMPLETED [1]   262 [2]   199 
NOT COMPLETED   75   98 
Adverse Event                5                3 
Lost to Follow-up                17                33 
Withdrawal by Subject                21                28 
Other-Clerical Error                3                0 
Other-Early termination                6                10 
Other-Procedure                1                1 
Other-Pregnancy                2                4 
Other-Protocol Violation                1                3 
Other-Lack of Efficacy                1                0 
Other-Non Compliance                2                0 
Other-Physician Decision                1                1 
Other-Sponsor Decision                10                12 
Other-Study Termination                0                1 
Other-Study Withdrawn                1                1 
Other-Site Stopped Communicating                2                0 
Other-Lost to Follow-up                1                0 
Other-Withdrawal by Subject                1                1 
[1] Completed Study is defined as had study drug and Week 5 visit.
[2] Two participants lacked study completion data: one site stopped communicating during the study.



  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.
All participants

Reporting Groups
  Description
Received Ferumoxytol in IDA-303 Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139]. Participants in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit, (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.
Did Not Receive Ferumoxytol in IDA-303 Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [NCT01114139] and did not receive ferumoxytol during AMAG-FER-IDA-303.
Total Total of all reporting groups

Baseline Measures
   Received Ferumoxytol in IDA-303   Did Not Receive Ferumoxytol in IDA-303   Total 
Overall Participants Analyzed 
[Units: Participants]
 337   297   634 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.0  (13.33)   43.8  (13.26)   44.9  (13.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      304  90.2%      269  90.6%      573  90.4% 
Male      33   9.8%      28   9.4%      61   9.6% 


  Outcome Measures

1.  Primary:   Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol   [ Time Frame: TP Baseline (Day 1), TP Week 5 ]

2.  Secondary:   Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course   [ Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3 ]

3.  Secondary:   Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5   [ Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3 ]

4.  Secondary:   Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol   [ Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3 ]

5.  Secondary:   Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol   [ Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3 ]

6.  Secondary:   Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol   [ Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3 ]

7.  Secondary:   Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline   [ Time Frame: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3 ]


  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
No text entered.


  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: NCT01114217     History of Changes
Other Study ID Numbers: AMAG-FER-IDA-303
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