Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01155388
Study type Interventional
Source AMAG Pharmaceuticals, Inc.
Contact
Status Terminated
Phase Phase 3
Start date October 17, 2011
Completion date June 24, 2014

See also
  Status Clinical Trial Phase
Recruiting NCT06027801 - Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity N/A
Completed NCT02282553 - Gastric Capsule Examination for Iron Deficiency Anaemia N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting NCT04913649 - Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients Phase 4
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT01307007 - Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding Phase 2
Completed NCT00982007 - Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA) Phase 3
Completed NCT00198848 - Iron Supplementation Among Adolescent Girls in India N/A
Completed NCT01166451 - The Anemia Control Program: High or Low Iron Supplementation N/A
Recruiting NCT03893045 - A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects Phase 3
Recruiting NCT03817957 - Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency Phase 3
Completed NCT03819530 - Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study N/A
Completed NCT03618914 - Anemia and Inflammation
Completed NCT03940430 - Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students Phase 2/Phase 3
Withdrawn NCT03873584 - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Completed NCT03237065 - Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Phase 3
Completed NCT05153278 - IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department