{"id":"placebo-of-iron-carboxymaltose","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL2108597","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a placebo, this formulation is inert and produces no pharmacological effect. It is used in clinical trials as a control comparator to evaluate the efficacy and safety of the active iron carboxymaltose formulation. Any observed effects in the placebo group represent baseline disease progression or non-specific responses.","oneSentence":"This is a placebo control arm and contains no active pharmaceutical ingredient.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:28:14.199Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in iron deficiency anemia trials"}]},"trialDetails":[{"nctId":"NCT07359599","phase":"PHASE4","title":"The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension","status":"RECRUITING","sponsor":"Ziekenhuis Oost-Limburg","startDate":"2026-01-27","conditions":"Pulmonary Hypertension, Iron Deficiency","enrollment":306},{"nctId":"NCT02632760","phase":"PHASE4","title":"Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery","status":"COMPLETED","sponsor":"Bayside Health","startDate":"2016-07-15","conditions":"Anaemia","enrollment":955},{"nctId":"NCT07217873","phase":"PHASE2, PHASE3","title":"IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study","status":"RECRUITING","sponsor":"Columbia University","startDate":"2025-11-21","conditions":"Scoliosis Correction, Iron Deficiency, Transfusion Blood","enrollment":120},{"nctId":"NCT05636774","phase":"NA","title":"Empower the Heart of Patients With Terminal Cancer Using Cardiac Medicines Trial","status":"COMPLETED","sponsor":"University Hospital, Essen","startDate":"2022-12-12","conditions":"Patients With Advanced Cancer Receiving Specialized Palliative Care","enrollment":97},{"nctId":"NCT05759078","phase":"PHASE4","title":"Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion","status":"RECRUITING","sponsor":"Wroclaw Medical University","startDate":"2022-09-22","conditions":"Myocardial Infarction, Acute","enrollment":1000},{"nctId":"NCT07057973","phase":"NA","title":"The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly","status":"RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2025-07-01","conditions":"Ferric Carboxymaltose","enrollment":100},{"nctId":"NCT03833336","phase":"PHASE3","title":"Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)","status":"COMPLETED","sponsor":"Institut de Recerca Biomèdica de Lleida","startDate":"2017-08-23","conditions":"Heart Failure With Normal Ejection Fraction, Ferropenic Anemia","enrollment":72},{"nctId":"NCT00740246","phase":"PHASE3","title":"Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2005-07","conditions":"Anemia","enrollment":594},{"nctId":"NCT04343170","phase":"NA","title":"Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction","status":"COMPLETED","sponsor":"Tanta University","startDate":"2023-09-01","conditions":"Ultra-short-term, Iron Deficiency Anemia, Scoliosis Idiopathic","enrollment":44},{"nctId":"NCT02826681","phase":"PHASE2","title":"Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia","status":"TERMINATED","sponsor":"American Regent, Inc.","startDate":"2017-07-10","conditions":"Restless Legs Syndrome (RLS)","enrollment":70},{"nctId":"NCT03680456","phase":"PHASE4","title":"Postoperative Replacement of Intraoperative Iron Losses","status":"COMPLETED","sponsor":"Kepler University Hospital","startDate":"2020-03-06","conditions":"Blood Loss Anemia","enrollment":134},{"nctId":"NCT03036462","phase":"PHASE4","title":"Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality","status":"COMPLETED","sponsor":"Universitätsklinikum Hamburg-Eppendorf","startDate":"2017-03-07","conditions":"Systolic Heart Failure, Iron Deficiency","enrollment":1105},{"nctId":"NCT03769441","phase":"PHASE3","title":"Effect of Ferric Carboxymaltose on Exercise Capacity After Kidney Transplantation","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2019-08-02","conditions":"Iron-deficiency, Transplant-Related Disorder","enrollment":148},{"nctId":"NCT03037931","phase":"PHASE3","title":"Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2017-03-15","conditions":"Heart Failure, Iron-deficiency","enrollment":3065},{"nctId":"NCT06442111","phase":"NA","title":"The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy","status":"NOT_YET_RECRUITING","sponsor":"Seoul St. Mary's Hospital","startDate":"2024-07-01","conditions":"Pancreaticojuodenectomy","enrollment":106},{"nctId":"NCT06434025","phase":"PHASE3","title":"IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency","status":"NOT_YET_RECRUITING","sponsor":"Hospital de Clinicas de Porto Alegre","startDate":"2024-05-24","conditions":"Heart Failure, Systolic, Iron Deficiencies","enrollment":99},{"nctId":"NCT03074591","phase":"PHASE4","title":"Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2017-08-01","conditions":"Iron-deficiency, Heart Failure","enrollment":40},{"nctId":"NCT03991000","phase":"PHASE3","title":"Iron in Patients With Cardiovascular Disease","status":"TERMINATED","sponsor":"Dr. med. Mahir Karakas","startDate":"2019-02-28","conditions":"Cardiovascular Diseases, Anemia, Iron-deficiency, Acute Myocardial Infarction","enrollment":8},{"nctId":"NCT03218384","phase":"PHASE2","title":"Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency","status":"TERMINATED","sponsor":"NYU Langone Health","startDate":"2017-09-07","conditions":"Iron-deficiency","enrollment":20},{"nctId":"NCT05098249","phase":"PHASE4","title":"Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia","status":"COMPLETED","sponsor":"Donat R. Spahn","startDate":"2021-11-11","conditions":"Anemia, Iron-deficiency, Hypophosphatemia","enrollment":92},{"nctId":"NCT01975272","phase":"PHASE4","title":"The Use of Iron Therapy for Patients With Anemia After Caesarean Section","status":"TERMINATED","sponsor":"Maastricht University Medical Center","startDate":"2015-03-02","conditions":"Postoperative Anaemia","enrollment":27},{"nctId":"NCT03388385","phase":"PHASE4","title":"Acute Effects of Intravenous Iron on Oxidative Stress and Endothelial Dysfunction in Non-dialysis CKD","status":"UNKNOWN","sponsor":"Carol Davila University of Medicine and Pharmacy","startDate":"2017-09-20","conditions":"Renal Anemia, Iron Toxicity, Oxidative Stress","enrollment":40},{"nctId":"NCT05477498","phase":"PHASE4","title":"Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction","status":"WITHDRAWN","sponsor":"Cantonal Hosptal, Baselland","startDate":"2021-12-01","conditions":"Heart Failure With Normal Ejection Fraction, Iron-deficiency","enrollment":""},{"nctId":"NCT02308449","phase":"NA","title":"Iron Status and Human Metabolism","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2014-10","conditions":"Iron Deficiency","enrollment":29},{"nctId":"NCT01447628","phase":"PHASE2","title":"IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients","status":"COMPLETED","sponsor":"Imperial College London","startDate":"2011-03-29","conditions":"Pulmonary Arterial Hypertension, Iron Deficiency","enrollment":56},{"nctId":"NCT04862715","phase":"PHASE4","title":"The Iron and Muscle Study","status":"COMPLETED","sponsor":"King's College Hospital NHS Trust","startDate":"2019-04-26","conditions":"CKD Stage 3, CKD Stage 4, Iron-deficiency","enrollment":75},{"nctId":"NCT00520780","phase":"PHASE3","title":"Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)","status":"COMPLETED","sponsor":"Vifor Pharma","startDate":"2007-04","conditions":"Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia","enrollment":456},{"nctId":"NCT02397057","phase":"PHASE3","title":"Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2015-01","conditions":"Restless Legs Syndrome (RLS)","enrollment":209},{"nctId":"NCT03759964","phase":"PHASE4","title":"Effects of Ferinject® on Anemia and Transfusion Rates After Cardiac Surgery","status":"COMPLETED","sponsor":"St Joseph University, Beirut, Lebanon","startDate":"2018-12-15","conditions":"Anemia, Iron Deficiency","enrollment":194},{"nctId":"NCT03380520","phase":"PHASE4","title":"Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy","status":"COMPLETED","sponsor":"Hasselt University","startDate":"2017-10-01","conditions":"Heart Failure","enrollment":75},{"nctId":"NCT02937454","phase":"PHASE4","title":"Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency","status":"COMPLETED","sponsor":"Vifor (International) Inc.","startDate":"2017-04-03","conditions":"Iron Deficiency, Heart Failure","enrollment":1132},{"nctId":"NCT04898569","phase":"PHASE4","title":"Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2019-02-10","conditions":"Coronary Artery Disease","enrollment":100},{"nctId":"NCT01374776","phase":"PHASE4","title":"Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women","status":"COMPLETED","sponsor":"University of Zurich","startDate":"2013-02","conditions":"Non Anemic Patients With Iron Deficiency (Low Ferritin Value)","enrollment":24},{"nctId":"NCT03574311","phase":"PHASE4","title":"Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery","status":"UNKNOWN","sponsor":"Turku University Hospital","startDate":"2018-10-02","conditions":"Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis","enrollment":210},{"nctId":"NCT04786769","phase":"PHASE4","title":"Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency","status":"UNKNOWN","sponsor":"Hospital de Santa Cruz, Portugal","startDate":"2022-01","conditions":"Aortic Stenosis, Iron-deficiency","enrollment":2500},{"nctId":"NCT04627181","phase":"PHASE4","title":"Do Iron And Vitamin B12 Injections Given Together, Improve Hemoglobin In Patients On Hemodialysis?","status":"UNKNOWN","sponsor":"Christian Medical College, Vellore, India","startDate":"2020-11-18","conditions":"Iron Deficiency Anemia, B12 Deficiency Anemia","enrollment":100},{"nctId":"NCT04510870","phase":"PHASE4","title":"Iron Deficiency as an Ignored Cause of Infertility","status":"UNKNOWN","sponsor":"Dextra Fertility Clinic","startDate":"2020-08-17","conditions":"Iron Deficiency, Infertility","enrollment":62},{"nctId":"NCT04475887","phase":"PHASE4","title":"Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation","status":"UNKNOWN","sponsor":"Medical University of Vienna","startDate":"2020-07-23","conditions":"Liver Transplantation, Blood Loss","enrollment":60},{"nctId":"NCT03191201","phase":"PHASE4","title":"A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.","status":"TERMINATED","sponsor":"Prof Gérard WAEBER","startDate":"2017-06-21","conditions":"Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus)","enrollment":32},{"nctId":"NCT04168346","phase":"PHASE4","title":"Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer","status":"NOT_YET_RECRUITING","sponsor":"Helsinki University Central Hospital","startDate":"2019-11","conditions":"Gastric Cancer, Anemia, Surgery","enrollment":202},{"nctId":"NCT02544464","phase":"PHASE4","title":"Does Intraoperative Intravenous Iron Enhance Postoperative Oxygenation Profile in Total Knee Arthroplasty Surgery?","status":"COMPLETED","sponsor":"Konkuk University Medical Center","startDate":"2016-08","conditions":"Osteoarthritis","enrollment":76},{"nctId":"NCT03398681","phase":"PHASE4","title":"Changes in Myocardial Iron After Iron Administration","status":"COMPLETED","sponsor":"Fundación para la Investigación del Hospital Clínico de Valencia","startDate":"2017-05-01","conditions":"Heart Failure, Iron-deficiency","enrollment":53},{"nctId":"NCT01692418","phase":"PHASE3","title":"Preoperative Intravenous Iron to Treat Anaemia in Major Surgery","status":"COMPLETED","sponsor":"University College, London","startDate":"2014-01","conditions":"Anaemia","enrollment":487},{"nctId":"NCT01978028","phase":"PHASE4","title":"Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose","status":"TERMINATED","sponsor":"University of Zurich","startDate":"2013-10","conditions":"Heart Failure","enrollment":20},{"nctId":"NCT03561480","phase":"PHASE4","title":"Effect of Postoperative Ferric Carboxymaltose","status":"UNKNOWN","sponsor":"The Catholic University of Korea","startDate":"2018-06-11","conditions":"Postoperative Anemia, Knee Osteoarthritis, Total Knee Arthroplasty","enrollment":80},{"nctId":"NCT03561506","phase":"PHASE4","title":"Effect of Preoperative Ferric Carboxymaltose After Simultaneous Bilateral Total Knee Arthroplasty","status":"UNKNOWN","sponsor":"The Catholic University of Korea","startDate":"2018-06-11","conditions":"Postoperative Anemia, Knee Osteoarthritis, Total Knee Arthroplasty","enrollment":80},{"nctId":"NCT01382901","phase":"PHASE2","title":"Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2006-03","conditions":"Restless Legs Syndrome (RLS)","enrollment":45},{"nctId":"NCT02409459","phase":"PHASE2","title":"Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia","status":"COMPLETED","sponsor":"American Regent, Inc.","startDate":"2015-03","conditions":"Iron Deficiency, Fibromyalgia","enrollment":81},{"nctId":"NCT03305705","phase":"PHASE4","title":"Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue","status":"UNKNOWN","sponsor":"Albina Nowak, MD","startDate":"2017-10-23","conditions":"Fatigue, Iron-deficiency","enrollment":20},{"nctId":"NCT01690585","phase":"PHASE3","title":"Efficacy of Parenteral Iron Supplementation After Gastrointestinal Bleeding in Subjects Over 65","status":"COMPLETED","sponsor":"University Hospital, Rouen","startDate":"2013-01","conditions":"Gastrointestinal Hemorrhage, Anemia","enrollment":62},{"nctId":"NCT01922479","phase":"PHASE4","title":"Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure","status":"COMPLETED","sponsor":"National University Hospital, Singapore","startDate":"2013-09","conditions":"Heart Failure, Anemia, Iron Deficiency","enrollment":50},{"nctId":"NCT03014921","phase":"NA","title":"Impact of Iron Injection on Blood Donation","status":"UNKNOWN","sponsor":"Nicolas Leuenberger","startDate":"2016-12","conditions":"Iron Deficiency","enrollment":19},{"nctId":"NCT01725789","phase":"PHASE3","title":"Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)","status":"COMPLETED","sponsor":"National Cancer Center, Korea","startDate":"2012-11","conditions":"Anemia","enrollment":454},{"nctId":"NCT02939794","phase":"PHASE4","title":"The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery","status":"UNKNOWN","sponsor":"Rambam Health Care Campus","startDate":"2016-11","conditions":"Anemia","enrollment":200},{"nctId":"NCT01837082","phase":"PHASE3","title":"Iron in Congestive Heart Failure","status":"TERMINATED","sponsor":"University of Ulm","startDate":"2013-04","conditions":"Heart Failure, Iron Deficiency, Anemia","enrollment":18},{"nctId":"NCT02517151","phase":"PHASE2","title":"Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue","status":"UNKNOWN","sponsor":"Istituto Clinico Humanitas","startDate":"2014-10","conditions":"Chronic Fatigue, Inflammatory Bowel Disease","enrollment":36},{"nctId":"NCT01154491","phase":"PHASE3","title":"Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period","status":"COMPLETED","sponsor":"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","startDate":"2010-06","conditions":"Hip Fractures","enrollment":303},{"nctId":"NCT00821717","phase":"PHASE3","title":"EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure","status":"TERMINATED","sponsor":"Vifor Pharma","startDate":"2008-12","conditions":"Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia","enrollment":35},{"nctId":"NCT01453608","phase":"PHASE4","title":"A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency","status":"COMPLETED","sponsor":"Vifor Pharma","startDate":"2011-10","conditions":"Iron Deficiency, Chronic Heart Failure","enrollment":304},{"nctId":"NCT00706667","phase":"PHASE4","title":"Intravenous Ferric Carboxymaltose (Ferinject®) With or Without Erythropoietin in Patients Undergoing Orthopaedic Surgery","status":"TERMINATED","sponsor":"University of Zurich","startDate":"2008-05","conditions":"Iron Deficiency Anemia","enrollment":75},{"nctId":"NCT00978575","phase":"PHASE4","title":"Iron Substitution After Upper Gastro-Intestinal Bleeding","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2010-04","conditions":"Gastrointestinal Hemorrhage, Anemia","enrollment":97},{"nctId":"NCT01519830","phase":"PHASE4","title":"Iron Substitution in Blood Donors","status":"COMPLETED","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2012-01","conditions":"Fatigue","enrollment":405},{"nctId":"NCT00810004","phase":"PHASE3","title":"Maintenance Treatment of Iron Deficiency in IBD Patients","status":"COMPLETED","sponsor":"Vifor Pharma","startDate":"2009-02","conditions":"Iron Deficiency, Inflammatory Bowel Disease","enrollment":245},{"nctId":"NCT01110356","phase":"PHASE4","title":"Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age","status":"COMPLETED","sponsor":"Vifor Pharma","startDate":"2010-06","conditions":"Iron Deficiency","enrollment":294},{"nctId":"NCT00882414","phase":"PHASE2","title":"Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)","status":"TERMINATED","sponsor":"Vifor Pharma","startDate":"2006-12","conditions":"Thrombocytosis, Iron-Deficiency Anemia","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Saline"],"phase":"phase_3","status":"active","brandName":"Placebo of Iron Carboxymaltose","genericName":"Placebo of Iron Carboxymaltose","companyName":"Hospital de Clinicas de Porto Alegre","companyId":"hospital-de-clinicas-de-porto-alegre","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This is a placebo control arm and contains no active pharmaceutical ingredient. Used for Control arm in iron deficiency anemia trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}