[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100361824":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":72,"collaborators":74,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Iron therapy","EXPERIMENTAL","Participant will receive oral iron therapy.",[13],"Drug: Ferrous Sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"No oral iron therapy","NO_INTERVENTION","Participant will not receive oral iron therapy for 3 months.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ferrous Sulfate","Oral iron will be given in the form of immediate-release iron sulfate, 3-6 mg\u002Fkg\u002Fday of elemental iron to children with body weight ≤43 kg, and 65 mg of elemental iron (325 mg of iron sulfate) to children with body weight \\>43 kg.",[9],[26],"iron sulfate",[28],{"name":29,"affiliation":30,"role":31},"Oleh Akchurin, M.D.","Weill Cornell College of Medicine","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Akeem Noziere, B.S.","CONTACT","646-962-8313","akn4001@med.cornell.edu",[39,55],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Weill Cornell Medicine \u002F New York Presbyterian Hospital","RECRUITING","New York","10065","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},[53,54],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},{"name":29,"role":31,"phone":18,"phoneExt":18,"email":18},{"facility":56,"status":41,"city":57,"state":58,"zip":59,"country":44,"countryCode":45,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":47,"coordinates":61},[62,63],-75.16362,39.95238,{"lat":63,"lon":62},[66,70],{"name":67,"role":35,"phone":68,"phoneExt":18,"email":69},"Jill Loguidice","267-425-4541","loguidicej@chop.edu",{"name":71,"role":31,"phone":18,"phoneExt":18,"email":18},"Amy Kogon, M.D., M.P.H.",{"type":73,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[75],{"name":56,"class":6},"100361824","phase-4-oral-iron-in-children-with-chronic-kidney-disease-100361824",false,"NCT03991169","Oral Iron in Children With Chronic Kidney Disease","Pilot Pragmatic Clinical Trial of Oral Iron Therapy in Children With Chronic Kidney Disease","FeTCh-CKD","Key inclusion criteria:\n\n* Age 1-21 years old (muscle strength will be assessed only in children \\>3 year old)\n* Estimated glomerular filtration rate (GFR) \\\u003C 90 ml\u002Fmin\u002F1.73m2 by bedside Schwartz formula \\[height (cm) \\*0.413 \u002F serum creatinine (mg\u002FdL)\\]\n* Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit\n* Hb less than 11.5 g\u002FdL in children younger than 5 years Hb less than 12.0 g\u002FdL in children 5-12 years Hb \\\u003C12.5 g\u002FdL in children 12-15 yrs and females \\>15 yrs. Hb \\\u003C13.5 g\u002FdL in males \\>15 years (all at the previous clinic visit)\n\nChildren with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng\u002FmL will be randomized into one of the arms\n\nKey exclusion criteria:\n\n* Transferrin saturation \\\u003C5%\n* Serum ferritin \\\u003C 10 ng\u002FmL\n* Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization\n* Blood transfusion within 4 months prior to enrollment\n* Children on hemodialysis\n* Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months\n* Pregnancy and breast-feeding","ALL","1 Year","21 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.",[95,96],"Chronic Kidney Insufficiency","Chronic Kidney Diseases",[98,99,100,101,102,103,104],"Anemia","Iron","Children","Chronic kidney disease (CKD)","Appetite","Physical activity","Muscle strength","2025-08-05",{"date":107,"type":108},"2025-08-11","ACTUAL",{"date":110,"type":108},"2019-04-19",{"date":112,"type":89},"2028-12-31",{"name":5,"class":6},2]