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The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg\u002FmL).",[15],[30],"Venofer",[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Clinical Trial Interest","CONTACT","1-877-374 -4177","CTInterest@covispharma.com",[38,52,63,74,84,92,101,111,121,131,139,149,157,165,175,180,188,196,206,214,219],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"Memorial Healthcare System","NOT_YET_RECRUITING","Hollywood","Florida","33021","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.14949,26.0112,{"lat":50,"lon":49},{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":62,"contacts":11},"Wayne State University","ACTIVE_NOT_RECRUITING","Detroit","Michigan","48201",{"type":47,"coordinates":59},[60,61],-83.04575,42.33143,{"lat":61,"lon":60},{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":44,"countryCode":45,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"Children's Mercy Hospital","RECRUITING","Kansas City","Missouri","64108",{"type":47,"coordinates":70},[71,72],-94.57857,39.09973,{"lat":72,"lon":71},{"facility":75,"status":40,"city":76,"state":77,"zip":78,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"The Feinstein Institute Medical Research Organization of Northwell Health, Inc.","Lake Success","New York","11042",{"type":47,"coordinates":80},[81,82],-73.71763,40.77066,{"lat":82,"lon":81},{"facility":85,"status":54,"city":77,"state":77,"zip":86,"country":44,"countryCode":45,"cosmosGeoPoint":87,"geoPoint":91,"contacts":11},"Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)","10029",{"type":47,"coordinates":88},[89,90],-74.00597,40.71427,{"lat":90,"lon":89},{"facility":93,"status":65,"city":94,"state":77,"zip":95,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":11},"Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)","The Bronx","10467",{"type":47,"coordinates":97},[98,99],-73.86641,40.84985,{"lat":99,"lon":98},{"facility":102,"status":65,"city":103,"state":104,"zip":105,"country":44,"countryCode":45,"cosmosGeoPoint":106,"geoPoint":110,"contacts":11},"Akron Nephrology Associates, Inc.","Akron","Ohio","44302",{"type":47,"coordinates":107},[108,109],-81.51901,41.08144,{"lat":109,"lon":108},{"facility":112,"status":65,"city":113,"state":114,"zip":115,"country":44,"countryCode":45,"cosmosGeoPoint":116,"geoPoint":120,"contacts":11},"West Virginia University","Morgantown","West Virginia","26506",{"type":47,"coordinates":117},[118,119],-79.9559,39.62953,{"lat":119,"lon":118},{"facility":122,"status":65,"city":123,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":11},"Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. 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Zamenhofa w Bialystoku","Bialystok","Poland","PL",{"type":47,"coordinates":202},[203,204],23.16433,53.13333,{"lat":204,"lon":203},{"facility":207,"status":54,"city":208,"state":11,"zip":11,"country":199,"countryCode":200,"cosmosGeoPoint":209,"geoPoint":213,"contacts":11},"Specjalistyczne Gabinety Sp. z o.o","Krakow",{"type":47,"coordinates":210},[211,212],19.93658,50.06143,{"lat":212,"lon":211},{"facility":215,"status":40,"city":208,"state":11,"zip":11,"country":199,"countryCode":200,"cosmosGeoPoint":216,"geoPoint":218,"contacts":11},"University Children Hospital",{"type":47,"coordinates":217},[211,212],{"lat":212,"lon":211},{"facility":220,"status":40,"city":221,"state":11,"zip":11,"country":199,"countryCode":200,"cosmosGeoPoint":222,"geoPoint":226,"contacts":11},"Polish Mother's Memorial Hospital Research Institute","Lodz",{"type":47,"coordinates":223},[224,225],19.47395,51.77058,{"lat":225,"lon":224},{"type":228,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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",false,"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","ALL","2 Years","17 Years",{"count":240,"type":241},129,"ESTIMATED","INTERVENTIONAL",[244],"PHASE3","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.",[247],"Chronic Kidney Disease; Iron Deficiency Anemia",[249,250,251,252,253,25,30],"Iron deficiency anemia (IDA)","chronic kidney disease (CKD)","pediatrics","ferumoxytol","iron sucrose","2026-04-14",{"date":256,"type":257},"2026-04-17","ACTUAL",{"date":259,"type":257},"2018-08-13",{"date":261,"type":241},"2026-08-31",{"name":5,"class":6},21]