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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent 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-252 study as designed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155388
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.
  Purpose
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).

Condition Intervention Phase
Iron Deficiency Anemia Nondialysis-dependent Chronic Kidney Disease Drug: Ferumoxytol Drug: Oral Iron Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Nondialysis-dependent Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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-252 and AMAG FER-CKD-251 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Actual Study Start Date: October 17, 2011
Study Completion Date: June 24, 2014
Primary Completion Date: June 24, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ferumoxytol
Experimental: 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.
Drug: Oral Iron
Active Comparator: Oral iron
Other Name: Ferrous fumarate

Detailed Description:

Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria for this study include:

  1. Males or females 6 months to <18 years of age
  2. Nondialysis dependent CKD, including kidney transplant recipients
  3. Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter (dL) and b) transferrin saturation level <20%
  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 for this study include:

  1. History of allergy to either oral or IV iron
  2. Allergy to two or more classes of drugs
  3. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
  4. Hemoglobin level ≤7.0 g/dL
  5. Serum ferritin level >600 nanograms/milliliter
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155388


Locations
United States, Massachusetts
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01155388     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-252
First Submitted: June 30, 2010
First Posted: July 1, 2010
Results First Submitted: August 10, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
Feraheme
ferumoxytol
CKD
pediatric
nondialysis-dependent

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferrous fumarate
Ferrosoferric Oxide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions