[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lucie Favre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100543060","phase-4-iv-iron-induced-hypophosphatemia-after-rygb-100543060",false,"NCT06350955","IV Iron-induced Hypophosphatemia After RYGB","Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)","IVORY","Inclusion Criteria:\n\n* Patients over 18 years\n* Signed informed consent\n* Patients with previous RYGB surgery performed \\> 12 months ago\n* Failed response to oral iron supplementation\n* Established diagnosis of iron deficiency by ferritin \\\u003C 50 ug\u002Fl or serum ferritin ≤100ug\u002Fl and low transferrin saturation (TSAT) ≤ 30%\n* Normal phosphate blood level (0.8 - 1.45 mmol\u002Fl) before infusion\n* Normal magnesium blood level (0.65-1.05 mmol\u002Fl)\n* Outpatient\n\nExclusion Criteria:\n\n* \\- Patients with known hypersensitivity to iron preparation and\u002For anaphylaxis from any cause\n* Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)\n* Women who are pregnant or breastfeeding\n* Intention to become pregnant during the course of the study\n* Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml\u002Fmin\u002F1.73m2)\n* Patients who received IV iron infusion during the last 3 months before screening\n* Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion within the last 3 months prior to screening\n* Alcohol or drug abuse within the past 6 months\n* Planned surgical procedure within the clinical trial period\n* Surgery under general anaesthesia within the last 3 months prior to screening\n* Hyperparathyroidism\n* Kidney transplantation\n* Inability to follow study procedures or give informed consent\n* Use and inability to stop from V0 to study end, phosphate supplementation (except daily multivitamin preparation recommended after bariatric surgery; the exact amount of phosphate and iron supplementation in the daily multivitamin will be recorded)\n* Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators).\n* Patient who refuses to be informed of incidental discoveries that may contribute to the prevention, diagnosis, and treatment of existing or probable future illnesses.","ALL","18 Years","99 Years",{"count":21,"type":22},94,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).",[28,29],"Hypophosphatemia","Roux-en-Y Gastric Bypass","RECRUITING","2024-08-19",{"date":33,"type":34},"2024-08-20","ACTUAL",{"date":36,"type":34},"2024-05-02",{"date":38,"type":22},"2026-06",{"name":40,"class":41},"Lucie Favre","OTHER",""]