| Trial ID: | L1365 |
| Source ID: | NCT01155388
|
| Associated Drug: |
Ferumoxytol
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| Title: |
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
TERMINATED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01155388/results
|
| Conditions: |
Iron Deficiency Anemia|Nondialysis-dependent Chronic Kidney Disease
|
| Interventions: |
DRUG: Ferumoxytol|DRUG: Oral Iron
|
| Outcome Measures: |
Primary: Mean Change In Hemoglobin From Baseline To 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., Baseline, Week 5 | Secondary: Pharmacokinetics: Area Under The Curve Of Ferumoxytol, 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., Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose
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| Sponsor/Collaborators: |
Sponsor: AMAG Pharmaceuticals, Inc.
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| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
14
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-10-17
|
| Completion Date: |
2014-06-24
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| Results First Posted: |
2017-11-06
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| Last Update Posted: |
2022-04-28
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| Locations: |
AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, 02451, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01155388
|
