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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

This study has been terminated.
(Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-251 study as designed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155375
First Posted: July 1, 2010
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
Results First Submitted: August 10, 2017  
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: Oral Iron

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 (NCT01155388) was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The results for the combined studies are included in this record.

Reporting Groups
  Description
Ferumoxytol

Participants received 1 of the following 2 ferumoxytol dose regimens:

  • Four intravenous (IV) injections of ferumoxytol 3.5 milligrams (mg) iron (Fe)/kilogram (kg) (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4).*Participants participating in pharmacokinetic (PK) sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
  • Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.
Oral Iron Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.

Participant Flow:   Overall Study
    Ferumoxytol   Oral Iron
STARTED [1]   8   6 
Received at Least 1 Dose of Study Drug   8   6 
COMPLETED   7   6 
NOT COMPLETED   1   0 
Adverse Event                1                0 
[1] Data are for the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies.



  Baseline Characteristics
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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.
The safety population is defined as participants who received any amount of study drug. Data are for the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies. The safety analysis is based on actual treatment received.

Reporting Groups
  Description
Ferumoxytol

Participants received 1 of the following 2 ferumoxytol dose regimens:

  • Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected.
  • Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.
Oral Iron Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
Total Total of all reporting groups

Baseline Measures
   Ferumoxytol   Oral Iron   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   6   14 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      8 100.0%      6 100.0%      14 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.2  (1.65)   13.8  (4.52)   14.6  (2.93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  62.5%      1  16.7%      6  42.9% 
Male      3  37.5%      5  83.3%      8  57.1% 


  Outcome Measures
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1.  Primary:   Mean Change In Hemoglobin From Baseline To Week 5   [ Time Frame: Baseline, Week 5 ]

2.  Secondary:   Pharmacokinetics: Area Under The Curve Of Ferumoxytol   [ Time Frame: Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
While sample data were collected, it was not run through any analysis to obtain the necessary outcome measure data. As such, summary of the data set is not possible.


  More Information
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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



Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01155375     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-251
First Submitted: June 28, 2010
First Posted: July 1, 2010
Results First Submitted: August 10, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017