Clinical trials: Ferric Carboxymaltose
Anemia
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
- Trial name
- NCT00548691
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 513 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
- Trial name
- NCT03523117
- Testing
- Ferric carboxymaltose, Ferrous Sulfate
- Where
- 16 sites in United States
- Volunteers
- 79 people
- Sponsor
- American Regent, Inc.
Anemia
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
- Trial name
- NCT00703937
- Testing
- Ferric Carboxymaltose (FCM), Standard Medical Care (SMC) for the treatment of IDA
- Where
- United States
- Volunteers
- 708 people
- Sponsor
- American Regent, Inc.
Heart Failure, Systolic, Iron Deficiency
Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency
Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency).
- Trial name
- Iron Turtle (NCT03079518)
- Testing
- Ferric Carboxymaltose, blood withdrawal
- Where
- Germany
- Volunteers
- 23 people
- Sponsor
- RWTH Aachen University
Pancreaticojuodenectomy
The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy
Iron deficiency anemia is well known as a risk factor that worsens postoperative morbidity and patient prognosis. Several studies have shown that intravenous iron administration before surgery is effective in reducing the risk of…
- Trial name
- Ferritin (NCT06442111)
- Testing
- The intravenous ferritin group
- Volunteers
- 106 people
- Sponsor
- Seoul St. Mary's Hospital
Iron Deficiency Anaemia, Iron Deficiency Anemia
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
- Trial name
- NCT03237065
- Testing
- Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
- Where
- 15 sites in United States
- Volunteers
- 122 people
- Sponsor
- Pharmacosmos A/S
Heart Failure
Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
The primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.
- Trial name
- NCT01978028
- Testing
- ferric carboxymaltose
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Hip Fractures, Anemia
The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients.
- Conditions
- Hip Fractures, Anemia, Complication,Postoperative
- Trial name
- NCT06080893
- Testing
- Ferric carboxymaltose
- Where
- Turkey (Türkiye)
- Volunteers
- 209 people
- Sponsor
- Istanbul University
Iron Deficiency Anemia
Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in…
- Trial name
- NCT01290315
- Testing
- Ferric Carboxymaltose (FCM), Iron Sucrose / Iron Dextran
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- American Regent, Inc.
Anemia, Cancer
Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
- Trial name
- NCT04246021
- Testing
- Ferric carboxymaltose (FCM)
- Volunteers
- 84 people
- Sponsor
- King Hussein Cancer Center
Systolic Heart Failure, Iron Deficiency
Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality
The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) extends the time-to-first-event of heart failure hospitalisations and cardiovascular (CV) death and reduces…
- Trial name
- FAIR-HF2 (NCT03036462)
- Testing
- Iron, Saline
- Where
- 51 sites in Germany, Hungary and 5 more
- Volunteers
- 1,105 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Iron-Deficiency Anemia
IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries.
- Trial name
- Ferinject (NCT02541708)
- Testing
- Ferric carboxymaltose, Ferrous sulfate + folic acid
- Where
- Tanzania
- Volunteers
- 230 people
- Sponsor
- Ifakara Health Institute
Postoperative Anemia, Osteoarthritis, Knee
Comparing Intravenous and Oral Iron in Postoperative Anemia
Postoperative anaemia are common in patients undergoing major orthopaedic surgery. The main consequence of perioperative anaemia is an increased risk of red blood cell (RBC) transfusions.
- Trial name
- NCT01913808
- Testing
- Ferric carboxymaltose, ferrous glycine sulphate
- Where
- Spain
- Volunteers
- 122 people
- Sponsor
- Parc de Salut Mar
Cerebral Aneurysm Unruptured, Iron Deficiency Anemia
Effect of Preoperative Intravenous Ferric Carboxymaltose for Clipping Surgery
Hypothesis: Correction of preoperative anemia can reduce the need for intra-/postoperative RBC transfusions and can improve surgical outcomes.
- Conditions
- Cerebral Aneurysm Unruptured, Iron Deficiency Anemia, Surgery
- Trial name
- PICASA (NCT04616092)
- Testing
- FEFINJECT
- Volunteers
- 130 people
- Sponsor
- Seoul National University Hospital
Healthy Adult
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants
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
- NCT06895993
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Injectafer®]
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Cancer and Chemotherapy Related Anemia
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for…
- Trial name
- IRON CLAD (NCT02453334)
- Testing
- Injectafer, Normal Saline
- Where
- 29 sites in United States
- Volunteers
- 244 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia (IDA)
Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs.
- Trial name
- NCT01950247
- Testing
- Injectafer, SOC
- Volunteers
- 1,025 people
- Sponsor
- American Regent, Inc.
Anemia, Major Abdominal Surgery
Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial
Preoperative anemia is common worldwide, ranging from 25% in knee arthroplasties to 60% in colorectal malignancies. In Singapore, about a quarter (27%) of all patients have anaemia prior to operation at a main tertiary center.
- Conditions
- Anemia, Major Abdominal Surgery, Pre-operative
- Trial name
- PIRCAS (NCT03295851)
- Testing
- Ferric carboxymaltose, Ferrous Fumarate
- Where
- Singapore
- Volunteers
- 60 people
- Sponsor
- Singapore General Hospital
Type 2 Diabetes Mellitus, Iron Deficiency
Ferric Carboxymaltose in Type 2 Diabetes Mellitus (T2DM) Patients With Iron Deficiency
The purpose of this study is to investigate the correlation between HbA1c and iron status in Type 2 Diabetes mellitus patients with iron deficiency by intravenous substitution of iron.
- Trial name
- CLEVER (NCT01513369)
- Testing
- ferric carboxymaltose, NaCl (0,9%)
- Where
- 6 sites in Germany
- Volunteers
- 152 people
- Sponsor
- GWT-TUD GmbH
Iron Deficiency Anemia, Impaired Renal Function
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron…
- Trial name
- REPAIR-IDA (NCT00981045)
- Testing
- Ferric Carboxymaltose (FCM), Iron Sucrose (Venofer)
- Where
- United States
- Volunteers
- 2,561 people
- Sponsor
- American Regent, Inc.