Clinical trials: Ferric Carboxymaltose
Iron Deficiency Anemia (IDA)
A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after…
- Trial name
- NCT02410213
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- 10 sites in Poland, Russia
- Volunteers
- 35 people
- Sponsor
- American Regent, Inc.
Malignant Neoplasms of Mesothelial and Soft Tissue, Gastrointestinal Stromal Tumor With Neurogenic Differentiation
Efficacy of Ferric Carboxymaltose in Gastrointestinal Stromal Tumor (GIST) Patients With Iron Deficiency Anemia (IDA) Receiving Systemic Therapy
The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose) with an iron supplement to learn which may be more effective in improving red blood cell counts in patients who have iron-deficiency…
- Trial name
- NCT02949947
- Testing
- Ferric Carboxymaltose, Iron Supplements, Questionnaire
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- M.D. Anderson Cancer Center
Healthy Adult
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition.
- Trial name
- NCT07606105
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Injectafer®]
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Solid Cancer Metastatic Disease, Lymphoid Disease
Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency
Anemia in patients with cancer is a common problem associated with an impaired quality of life. Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased…
- Trial name
- NCT02213653
- Testing
- ARM A : IV iron + epoietin zeta, ARM B: IV iron + epoietin zeta sequence, ARM C : single epoietin zeta
- Where
- 2 sites in France
- Volunteers
- 24 people
- Sponsor
- Centre Francois Baclesse
Postpartum Anemia Nos, Iron-deficiency
Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia
Anemia affects between 20 and 50 % of women in the postpartum period. It is associated with several adverse health consequences, such as impaired physical work capacity, deficits in cognitive function and mood, reduced immune…
- Trial name
- NCT03957057
- Testing
- Iron Carboxymaltose, Iron Isomaltoside, Ferrous sulphate
- Where
- Slovenia
- Volunteers
- 300 people
- Sponsor
- University Medical Centre Ljubljana
Iron-deficiency, Iron Toxicity
A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.
In this study the investigators aim at addressing potential relationships between iron stores and glucose homeostasis. Iron (i.e.
- Conditions
- Iron-deficiency, Iron Toxicity, Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Side Effects of Drugs
- Trial name
- DIAFER (NCT03191201)
- Testing
- Ferric Carboxymaltose, 0.9% sodium chloride solution
- Where
- Switzerland
- Volunteers
- 32 people
- Sponsor
- Prof Gérard WAEBER
Methemoglobinemia, Anemia, Iron-Deficiency
Ferric Carboxymaltose Methemoglobinemia Study
Anemia that develops due to iron deficiency is called iron deficiency anemia. This common condition is treated with iron supplements taken either orally or given through an intravenous (IV) infusion.
- Conditions
- Methemoglobinemia, Anemia, Iron-Deficiency, Parenteral Iron Therapy, Ferric Carboxymaltose
- Trial name
- FerMet (NCT06958822)
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- 23 sites in Turkey (Türkiye)
- Volunteers
- 977 people, healthy volunteers welcome
- Sponsor
- Ordu University
Chronic Heart Failure, Iron Deficiency
Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures.
- Conditions
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
- Trial name
- FAIR-HF (NCT00520780)
- Testing
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Where
- 48 sites in Argentina, Germany and 8 more
- Volunteers
- 456 people
- Sponsor
- Vifor Pharma
Iron Deficiency Anemia of Pregnancy
Iron Infusion Into a Vein Compared to Iron Tablet Taken by Mouth for Treating Iron Deficiency Anemia in Pregnancy (IVON)
Background: Anaemia in pregnancy is a public health burden with high incidence in Africa. Currently high dose oral iron is recommended for treatment of mild to moderate anaemia and blood transfusion for severe anaemia.
- Trial name
- IVON (NCT04976179)
- Testing
- Ferric carboxymaltose, Ferrous sulfate
- Where
- 11 sites in Nigeria
- Volunteers
- 1,056 people, healthy volunteers welcome
- Sponsor
- University of Lagos, Nigeria
Anemia
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease…
- Trial name
- NCT00317239
- Testing
- Ferrous Sulfate tablets, Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- American Regent, Inc.
Restless Legs Syndrome (RLS)
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
The pathophysiology of restless legs syndrome (RLS) is not well understood: it is thought to involve intracerebral iron deficiency and dopaminergic dysregulation.
- Trial name
- IRON-RLS (NCT07822607)
- Testing
- Ferric Carboxymaltose Injection [Ferinject], Randomization, Questionnaire and Physical Exam
- Where
- France
- Volunteers
- 66 people
- Sponsor
- University Hospital, Montpellier
Iron Deficiency Anemia
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have…
- Trial name
- NCT00982007
- Testing
- Ferric Carboxymaltose (FCM), Ferrous Sulfate Tablets, IV Iron (standard of care)
- Where
- United States
- Volunteers
- 997 people
- Sponsor
- American Regent, Inc.
Iron-deficiency, Valvular Heart Disease
Impact of Iron Deficiency and Its Correction on Mitochondrial Metabolism of the Cardiomyocyte (MitoCardioFer)
Iron is involved in essential functions of the body. It allows the transport of oxygen in the blood, via hemoglobin, at the muscular level, via myoglobin, and it is also involved in cellular metabolism in general, in particular…
- Trial name
- MitoCardioFer (NCT03541213)
- Testing
- myocardial biopsy, sternal bone marrow biopsy, blood sample
- Where
- France
- Volunteers
- 55 people
- Sponsor
- University Hospital, Angers
Anemia, Colorectal Carcinoma
Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia
The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the…
- Conditions
- Anemia, Colorectal Carcinoma, Surgery
- Trial name
- FIT (NCT02243735)
- Testing
- Ferrous fumarate, ferric(III)carboxymaltose
- Where
- 13 sites in Netherlands
- Volunteers
- 198 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Anemia
Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)
This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective measures (Hb and iron parameters).
- Trial name
- NCT01725789
- Testing
- Ferinject®, normal saline
- Where
- 6 sites in South Korea
- Volunteers
- 454 people
- Sponsor
- National Cancer Center, Korea
Myocardial Infarction, Iron-deficiency
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.
- Trial name
- OPERA-MI (NCT05309499)
- Testing
- ferric carboxymaltose, ferrous sulphate
- Where
- Russia
- Volunteers
- 298 people
- Sponsor
- Kazan State Medical University
Gastric Cancer (GC), Iron Deficiency Anemia (IDA)
Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric Cancer
This is a multicenter, open-label, randomized controlled trial. A total of 160 patients with iron-deficiency anemia after radical gastrectomy for gastric cancer will be enrolled and randomly assigned in a 1:1 ratio.
- Conditions
- Gastric Cancer (GC), Iron Deficiency Anemia (IDA), Post-Operative Anemia, Radical Gastrectomy
- Trial name
- IRIS (NCT07772453)
- Testing
- Ferric Carboxymaltose (FCM), Iron Sucrose.
- Volunteers
- 160 people
- Sponsor
- Zhaojian Niu,MD
Heart Failure, Iron-deficiency
Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency
The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron…
- Conditions
- Heart Failure, Iron-deficiency, Heart Failure, Systolic, Heart Failure NYHA Class II
- Trial name
- VICTORID-HF (NCT05702970)
- Testing
- Sucrosomial iron, Vitamin D, Ferric Carboxymaltose 50 MG/ML
- Volunteers
- 258 people
- Sponsor
- University of Padova
Iron Deficiency, Inflammatory Bowel Disease
Maintenance Treatment of Iron Deficiency in IBD Patients
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
- Trial name
- FER-IBD-MAIN (NCT00810004)
- Testing
- Ferinject
- Where
- Russia
- Volunteers
- 245 people
- Sponsor
- Vifor Pharma
Hypophosphatemia, Roux-en-Y Gastric Bypass
IV Iron-induced Hypophosphatemia After RYGB
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®).
- Trial name
- IVORY (NCT06350955)
- Testing
- Iron isomaltoside, Iron Carboxymaltose
- Where
- Switzerland
- Volunteers
- 94 people
- Sponsor
- Lucie Favre