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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)",[19],"Drug: Iron sucrose",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ferumoxytol","Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe\u002FmL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg\u002FmL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution",[9],[27],"Feraheme",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. 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],[32],"Venofer",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Clinical Trial Interest","CONTACT","1-877-374 -4177","CTInterest@covispharma.com",[41,55,65,75,81,91,101,111,119,127,137,145,153,161,169],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":33},"Arkansas Children's Hospital","NOT_YET_RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-92.28959,34.74648,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":58,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":33},"University of Florida","Gainesville","Florida","32608",{"type":50,"coordinates":61},[62,63],-82.32483,29.65163,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":58,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":33},"Optimus U Corporation","RECRUITING","Miami","33125",{"type":50,"coordinates":71},[72,73],-80.19366,25.77427,{"lat":73,"lon":72},{"facility":76,"status":67,"city":68,"state":58,"zip":77,"country":47,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":80,"contacts":33},"Biomedical Research LLC","33184",{"type":50,"coordinates":79},[72,73],{"lat":73,"lon":72},{"facility":82,"status":43,"city":83,"state":84,"zip":85,"country":47,"countryCode":48,"cosmosGeoPoint":86,"geoPoint":90,"contacts":33},"Gwinnett Research Institute","Buford","Georgia","30519",{"type":50,"coordinates":87},[88,89],-84.00435,34.12066,{"lat":89,"lon":88},{"facility":92,"status":67,"city":93,"state":94,"zip":95,"country":47,"countryCode":48,"cosmosGeoPoint":96,"geoPoint":100,"contacts":33},"Sun Research Institute","San Antonio","Texas","78215",{"type":50,"coordinates":97},[98,99],-98.49363,29.42412,{"lat":99,"lon":98},{"facility":102,"status":43,"city":103,"state":33,"zip":33,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":33},"JSC Saules seimos medicinos centras","Kaunas","Lithuania","LT",{"type":50,"coordinates":107},[108,109],23.90909,54.90156,{"lat":109,"lon":108},{"facility":112,"status":43,"city":113,"state":33,"zip":33,"country":104,"countryCode":105,"cosmosGeoPoint":114,"geoPoint":118,"contacts":33},"Klaipeda Children's Hospital","Klaipėda",{"type":50,"coordinates":115},[116,117],21.13912,55.7068,{"lat":117,"lon":116},{"facility":120,"status":43,"city":121,"state":33,"zip":33,"country":104,"countryCode":105,"cosmosGeoPoint":122,"geoPoint":126,"contacts":33},"Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos","Vilnius",{"type":50,"coordinates":123},[124,125],25.2798,54.68916,{"lat":125,"lon":124},{"facility":128,"status":43,"city":129,"state":33,"zip":33,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":33},"Osrodek Badan Klinicznych In Vivo sp. z o.o.","Bydgoszcz","Poland","PL",{"type":50,"coordinates":133},[134,135],18.00762,53.1235,{"lat":135,"lon":134},{"facility":138,"status":43,"city":139,"state":33,"zip":33,"country":130,"countryCode":131,"cosmosGeoPoint":140,"geoPoint":144,"contacts":33},"Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek","Dębica",{"type":50,"coordinates":141},[142,143],21.41141,50.05146,{"lat":143,"lon":142},{"facility":146,"status":43,"city":147,"state":33,"zip":33,"country":130,"countryCode":131,"cosmosGeoPoint":148,"geoPoint":152,"contacts":33},"Pro Familia Altera Sp. z o.o.","Katowice",{"type":50,"coordinates":149},[150,151],19.02173,50.2597,{"lat":151,"lon":150},{"facility":154,"status":43,"city":155,"state":33,"zip":33,"country":130,"countryCode":131,"cosmosGeoPoint":156,"geoPoint":160,"contacts":33},"Korczowski Bartosz, Gabinet Lekarski","Rzeszów",{"type":50,"coordinates":157},[158,159],21.99901,50.04132,{"lat":159,"lon":158},{"facility":162,"status":43,"city":163,"state":33,"zip":33,"country":130,"countryCode":131,"cosmosGeoPoint":164,"geoPoint":168,"contacts":33},"Centrum Zdrowia MDM","Warsaw",{"type":50,"coordinates":165},[166,167],21.01178,52.22977,{"lat":167,"lon":166},{"facility":170,"status":43,"city":171,"state":33,"zip":33,"country":130,"countryCode":131,"cosmosGeoPoint":172,"geoPoint":176,"contacts":33},"Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu","Wroclaw",{"type":50,"coordinates":173},[174,175],17.03006,51.10286,{"lat":175,"lon":174},{"type":178,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":190,"type":191},75,"ESTIMATED","INTERVENTIONAL",[194],"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).",[197],"Iron Deficiency Anemia",[199,200,201,23,202],"IDA","anemia","pediatrics","iron sucrose","2026-04-14",{"date":205,"type":206},"2026-04-17","ACTUAL",{"date":208,"type":206},"2019-09-18",{"date":210,"type":191},"2026-10",{"name":5,"class":6},15]