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.
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
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.
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.
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.
Iron Deficiency
Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age
research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.
- Trial name
- Prefer (NCT01110356)
- Testing
- Ferinject, Saline
- Where
- Austria
- Volunteers
- 294 people
- Sponsor
- Vifor Pharma
Anemia
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran 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
- NCT00704028
- Testing
- Ferric Carboxymaltose, Iron Dextran
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- American Regent, Inc.
Iron Deficiency, Anaemia
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 year) with Iron Deficiency Anemia.
- Trial name
- NCT04968379
- Testing
- Ferric carboxymaltose
- Where
- 4 sites in United States
- Sponsor
- American Regent, Inc.
Inflammatory Bowel Disease, Anemia
FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR
The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.
- Conditions
- Inflammatory Bowel Disease, Anemia, Iron Deficiency, Iron-Deficiency Anemia
- Trial name
- FER-IBD-COR (NCT00810030)
- Testing
- Ferric carboxymaltose, Iron Sucrose
- Where
- Austria
- Volunteers
- 484 people
- Sponsor
- Vifor Pharma
Iron Deficiency Anaemia, Iron Deficiency Anemia
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs 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
- NCT03238911
- Testing
- Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
- Where
- 16 sites in United States
- Volunteers
- 123 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anemia
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
- Trial name
- NCT02694978
- Testing
- Ferumoxytol, FCM
- Where
- 127 sites in United States, Canada and 5 more
- Volunteers
- 2,014 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Anemia
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
- Trial name
- NCT00548860
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 2,018 people
- Sponsor
- American Regent, Inc.
Chronic Heart Failure, Iron Deficiency
EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory…
- Conditions
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
- Trial name
- EFFICACY-HF (NCT00821717)
- Testing
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Where
- 41 sites in Denmark, France and 3 more
- Volunteers
- 35 people
- Sponsor
- Vifor Pharma
Anemia
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease…
- Trial name
- NCT00317226
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- American Regent, Inc.
Iron Deficiency, Heart Failure
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency
Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)
- Trial name
- Affirm-AHF (NCT02937454)
- Testing
- ferric carboxymaltose, Normal saline 0.9%
- Where
- 16 sites in Argentina, Brazil and 13 more
- Volunteers
- 1,132 people
- Sponsor
- Vifor (International) Inc.
Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be…
- Trial name
- NCT02086968
- Testing
- Injectafer, Ferrous Sulfate tablets
- Volunteers
- 198 people
- Sponsor
- American Regent, Inc.