- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01155375
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Massachusetts
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Waltham, Massachusetts, United States, 02451
- AMAG Pharmaceuticals, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:
- Males or females 6 months to <18 years of age
- CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
- 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)
- 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:
- History of allergy to either oral or IV iron
- Hemoglobin level ≤7.0 g/dL
- Serum ferritin level >600 ng/mL
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ferumoxytol
Participants will receive 1 of the following 2 ferumoxytol dose regimens:
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Experimental: Ferumoxytol
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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.
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Active Comparator: Oral iron
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, Week 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urologic Diseases
- Hematologic Diseases
- Renal Insufficiency
- Nutrition Disorders
- Anemia, Hypochromic
- Iron Metabolism Disorders
- Malnutrition
- Kidney Diseases
- Renal Insufficiency, Chronic
- Anemia, Iron-Deficiency
- Anemia
- Deficiency Diseases
- Physiological Effects of Drugs
- Trace Elements
- Micronutrients
- Hematinics
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Ferrous fumarate
- Ferrosoferric Oxide
Other Study ID Numbers
- AMAG-FER-CKD-251
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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