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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.
June 28, 2010
July 1, 2010
August 10, 2017
November 6, 2017
November 6, 2017
October 17, 2011
June 24, 2014   (Final data collection date for primary outcome measure)
Mean Change In Hemoglobin From Baseline To Week 5 [ Time Frame: Baseline, Week 5 ]
Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.
Hemoglobin changes
Complete list of historical versions of study NCT01155375 on ClinicalTrials.gov Archive Site
Pharmacokinetics: Area Under The Curve Of Ferumoxytol [ Time Frame: Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose ]
Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.
Pharmacokinetic (PK) analysis
  • Maximum concentration (Cmax)
  • Area under the curve (AUC)
Not Provided
Not Provided
 
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared With Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Chronic Kidney Disease
Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Study AMAG-FER-CKD-251 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Study AMAG-FER-CKD-252 (NCT01155388) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest: Randomization was stratified by the following age cohorts: 12 to <18 years, 6 to <12 years, 2 to <6 years, and 6 months to <2 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Iron Deficiency Anemia
  • Drug: Ferumoxytol
    Experimental: Ferumoxytol
  • Drug: Oral Iron
    Active Comparator: Oral iron
    Other Name: Ferrous fumarate
  • Experimental: Ferumoxytol

    Participants will receive 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.
    Intervention: Drug: Ferumoxytol
  • Active Comparator: Oral Iron
    Participants will receive oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.
    Intervention: Drug: Oral Iron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
June 24, 2014
June 24, 2014   (Final data collection date for primary outcome measure)

Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

  1. Males or females 6 months to <18 years of age
  2. CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
  3. Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level <100 nanograms/milliliter (ng/mL)
  4. Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study

Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

  1. History of allergy to either oral or IV iron
  2. Hemoglobin level ≤7.0 g/dL
  3. Serum ferritin level >600 ng/mL
  4. Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test
Sexes Eligible for Study: All
6 Months to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01155375
AMAG-FER-CKD-251
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP