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Clinical Trial Details

Trial ID: L1642
Source ID: NCT01264679
Associated Drug: Ferumoxytol
Title: A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01264679/results
Conditions: Iron Deficiency Anemia
Interventions: DRUG: Ferumoxytol
Outcome Measures: Primary: Mean Change In Hemoglobin From Baseline To Week 5, Mean changes in hemoglobin following the first course of ferumoxytol 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, and the AMAG-FER-CKD-253 study. 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: Proportion Of Participants With An Increase In Hemoglobin From Baseline To Week 5 And To Week 7, The proportion of participants with an increase hemoglobin to ≥1.0 g/dL or to ≥12.0 g/dL during the period from Baseline to Week 5 and to Week 7 following each course of ferumoxytol was to be presented. However, 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, and the AMAG-FER-CKD-253 study. 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, Week 5 and Week 7|Mean Change In TSAT From Baseline To Week 5 And To Week 7, Mean changes in TSAT following the first course of ferumoxytol from Baseline to Week 5 and to Week 7 were to be presented. However, 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, and the AMAG-FER-CKD-253 study. 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, Week 5 and Week 7
Sponsor/Collaborators: Sponsor: AMAG Pharmaceuticals, Inc.
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 8
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12-27
Completion Date: 2015-04-24
Results First Posted: 2017-11-06
Last Update Posted: 2022-04-28
Locations: AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, 02451, United States
URL: https://clinicaltrials.gov/show/NCT01264679