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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferumoxytol	Experimental: Ferumoxytol
DRUG	Oral Iron	Active Comparator: Oral iron

Timeline

• Start date: 2011-10-17
• Primary completion: 2014-06-24
• Completion: 2014-06-24
• First posted: 2010-07-01
• Last updated: 2022-04-04
• Results posted: 2017-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study