[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iron-deficiency-anaemia-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iron-deficiency-anaemia-in-children":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100453031","phase-3-multi-center-trial-of-ferric-derisomaltose-in-children-0-to-18-years-of-age-with-iron-deficiency-anemia-100453031",false,"NCT05179226","Multi-center Trial of Ferric Derisomaltose in Children 0 to \u003C18 Years of Age With Iron Deficiency Anemia","A Phase III, Prospective, Open-label, Multi-center Trial of Ferric Derisomaltose in Children 0 to \u003C18 Years of Age With Iron Deficiency Anemia Due to NDD-CKD or With Iron Deficiency Anemia Who Are Intolerant or Unresponsive to Oral Iron","Inclusion Criteria:\n\n* Subjects \\\u003C18 years\n* Informed consent and child assent, as age-appropriate, obtained before any trial- related activities and willingness to participate. LAR of the subject must sign and date the ICF (according to local requirements). The child must sign and date the CAF or provide oral assent, if required according to local requirements\n* IDA caused by different etiologies such as gastrointestinal disease, NDD-CKD, or other conditions leading to IDA\n* Hb concentration less than the 5th percentile for age and sex-specific reference range (Appendix B)\n* Subjects with NDD-CKD (a) or who are intolerant or unresponsive to oral iron (b):\n\n  a) Subjects with NDD-CKD:\n* TSAT ≤35 % or s-ferritin \\\u003C100 ng\u002FmL\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2\n* If on ESA, receiving stable ESA regimen defined as dose adjustments no more than\n\n  ± 20 % for ≥8 weeks prior to screening\n\n  b) Subjects with documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to trial enrolment.\n* TSAT ≤20 % or s-ferritin \\\u003C100 ng\u002FmL\n\nExclusion Criteria:\n\n* Anemia caused by factors other than IDA according to Investigator's judgment\n* S-ferritin \\>600 ng\u002FmL\n* Hb ≤5.0 g\u002FdL\n* Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis)\n* ALAT and\u002For ASAT \\>2 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis)\n* Pregnant or nursing female subjects. In order to avoid pregnancy, female subjects of childbearing potential have to use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) or be abstinent during the whole trial period and 7 days after the last dosing. Childbearing potential refers to all female subjects ≥12 years old or \\\u003C12 years old who have started menstruating\n* Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose\n* Received an investigational drug within 30 days prior to screening\n* Treatment with IV iron within 10 days prior to screening\n* Treatment with blood transfusion, radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 30 days prior to screening\n* Planned elective surgery (or planned surgery during the trial period) where significant blood loss is expected within the last 30 days prior to screening\n* Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)\n* Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements","ALL","17 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Several clinical trials have been reported for ferric derisomaltose where it has been shown to be well tolerated and to improve markers of IDA. All clinical trials with ferric derisomaltose have been performed in adults, however, IDA is not specific to the adult population. In fact, children are likely to develop IDA due to their rapid growth.\n\nThe aim in this trial is to evaluate the efficacy and safety of intravenous (IV) ferric derisomaltose in children 0 to \\\u003C18 years of age with IDA due to NDD-CKD or with IDA who are intolerant or unresponsive to oral iron .\n\nThe subjects will receive ferric derisomaltose\u002Firon isomaltoside 1000 (Monoferric®\u002FMonofer®), at single doses of 10 mg\u002Fkg or 20 mg\u002Fkg with a maximal dose of 1000 mg.\n\n24 subjects will be part of a PK assessment, meaning that more blood samples will be drawn within the first week after treatment. The blood samples will be used for analysis of the amount of total iron in the blood from treatment is given to day 7.\n\nFor the individual subject, duration of the trial will be approximately 10 weeks (including a 14-day screening period) and each subject will attend 6-9 visits. Subjects who will be included in the PK assessments will attend 8 (subjects age 6 to \\\u003C12 years old and 0 to \\\u003C6 years old) or 9 (subjects age 12 to \\\u003C18 years old) visits, while the other subjects will attend 6 visits.",[26],"Iron Deficiency, Anaemia in Children","RECRUITING","2026-04-09",{"date":30,"type":31},"2026-04-14","ACTUAL",{"date":33,"type":31},"2022-11-28",{"date":35,"type":20},"2026-04-30",{"name":37,"class":38},"Pharmacosmos A\u002FS","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":39},"100573149","comparison-of-efficacy-of-iron-polymaltose-complex-and-ferrous-sulphate-in-iron-deficiency-anemia-in-pediatric-patients-100573149","NCT06742528","Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients","Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients With Iron Deficiency Anemia","Inclusion Criteria:\n\n* Patients having iron deficiency anemia\n\nExclusion Criteria:\n\n1. Patients diagnosed as congenital aplastic anemia or thalassemia (Determined from medical record).\n2. Patients who were transfused in previous 4 weeks (will be determined on history)\n3. Children having mal-absorption syndrome and diarrheal illnesses. (will be determined on history and medical record)\n4. Gastrointestinal bleeding suggested by history of hematemesis (bloody vomit), melena (black colored stools) or bloody stools.",true,"6 Months","5 Years",{"count":51,"type":20},198,[53],"NA","This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.",[56,26],"Iron Deficiency Anemia",[58,59,26],"IRON POLMALTOSE COMPLEX","FERROUS SULPHATE","2024-12-17",{"date":62,"type":31},"2024-12-19",{"date":64,"type":31},"2024-01-10",{"date":66,"type":20},"2025-01-10",{"name":68,"class":69},"Arooj Khan","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":47,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":39},"100558760","pilot-trial-investigating-every-other-day-dosing-of-oral-iron-in-premature-infants-iqonic-100558760","NCT06555315","Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)","Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.","Inclusion Criteria:\n\n* Children (Minor \\\u003C 18 years of age)\n* Neonates\n* Hospitalized\n* Premature infants who are on full enteral feeds and are started on oral iron\n* Premature infants who completed 26 0\u002F7 to 32 6\u002F7 weeks' gestation at birth\n\nExclusion Criteria:\n\n• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization","26 Weeks","32 Weeks",{"count":80,"type":20},100,[53],"Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates",[84,85,86,26,87],"Very Low Birth Weight Infant","Premature Infants","Anemia of Prematurity","Extremely Low Birth Weight",[89,90,91,92],"Premature infants","Iron","anemia of prematurity","iron deficiency","2024-08-13",{"date":95,"type":31},"2024-08-15",{"date":97,"type":31},"2024-08-01",{"date":99,"type":20},"2026-03-28",{"name":101,"class":69},"CHRISTUS Health"]