[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AMAG Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100354295","phase-3-a-study-to-evaluate-ferumoxytol-for-the-treatment-of-iron-deficiency-anemia-ida-in-pediatric-subjects-100354295",false,"NCT03893045","A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects","A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects","Inclusion Criteria:\n\n1. Male or female 2 years to \\\u003C18 years of age at time of consent\n2. Has IDA defined as:\n\n   1. Hemoglobin (Hgb) \\\u003C11.0 g\u002FdL AND\n   2. Any one or more of the following:\n\n      * Transferrin saturation (TSAT) \\\u003C20%\n      * ferritin \\\u003C100 ng\u002FmL\n3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose\n2. History of allergy to intravenous (IV) iron\n3. History of ≥2 clinically significant drug allergies\n4. Subjects with CKD (defined as eGFR of \\\u003C60 mL\u002Fmin\u002F1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)\n5. Low systolic blood pressure (BP) (age 1 to 9 years \\\u003C70 + \\[age in years x 2\\] mmHg, age 10 to 17 years \\\u003C90 mmHg)\n6. Hgb ≤7.0 g\u002FdL\n7. Serum ferritin level \\>600 ng\u002FmL","ALL","2 Years","17 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \\\u003C18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).",[27],"Iron Deficiency Anemia",[29,30,31,32,33],"IDA","anemia","pediatrics","ferumoxytol","iron sucrose","RECRUITING","2026-04-14",{"date":37,"type":38},"2026-04-17","ACTUAL",{"date":40,"type":38},"2019-09-18",{"date":42,"type":21},"2026-10",{"name":44,"class":45},"AMAG Pharmaceuticals, Inc.","INDUSTRY",15,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100333325","phase-3-a-study-to-evaluate-the-safety-compared-to-iron-sucrose-efficacy-and-pharmacokinetics-of-ferumoxytol-for-the-treatment-of-iron-deficiency-anemia-ida-in-pediatric-subjects-with-chronic-kidney-disease-ckd-100333325","NCT03619850","A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)","A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)","Inclusion Criteria:\n\n1. Male or female 2 years to \\\u003C18 years of age at time of consent\n2. Has IDA defined as: a) hemoglobin \\\u003C12.0 g\u002FdL and b) with either transferrin saturation (TSAT) \\\u003C40% or ferritin \\\u003C100 ng\u002FmL; or considered to be at risk of development of IDA, i.e., TSAT\\\u003C20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin \\\u003C12 g\u002FdL\n3. Has Chronic Kidney Disease defined as one of the following:\n\n   1. on chronic hemodialysis;\n   2. receiving chronic peritoneal dialysis;\n   3. estimated glomerular filtration rate (eGFR) of \\\u003C60 mL\u002Fmin\u002F1.73 m2;\n   4. has evidence of structural and\u002For functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for \\> 3 months.\n4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate\n5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose\n2. History of allergy to intravenous (IV) iron\n3. History of multiple drug allergies (\\>2)\n4. Low systolic blood pressure (Age 1-9 years \\\u003C70 + \\[age in years x 2\\] mmHg, Age 10-17 years \\\u003C90 mmHg)\n5. Hemoglobin ≤7.0 g\u002FdL\n6. Serum ferritin level \\>600 ng\u002FmL",{"count":55,"type":21},129,[24],"Primary Objectives:\n\nTo evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA\n\nSecondary Objective:\n\nTo determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.",[59],"Chronic Kidney Disease; Iron Deficiency Anemia",[61,62,31,32,33,63,64],"Iron deficiency anemia (IDA)","chronic kidney disease (CKD)","Feraheme","Venofer",{"date":37,"type":38},{"date":67,"type":38},"2018-08-13",{"date":69,"type":21},"2026-08-31",{"name":44,"class":45},21,""]