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.
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
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.
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
Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF).
- Trial name
- NCT03218384
- Testing
- Ferric Carboxymaltose, 31P MRS/MRI
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NYU Langone Health
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.
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.
Iron Deficiency Anaemia, Chronic Kidney Disease
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron…
- Trial name
- FIND-CKD (NCT00994318)
- Testing
- FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, Oral Iron (Ferrous sulphate)
- Where
- 19 sites in United States, Australia and 17 more
- Volunteers
- 626 people
- Sponsor
- Vifor Pharma
Restless Legs Syndrome (RLS)
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5.
- Trial name
- NCT02397057
- Testing
- Injectafer
- Where
- 19 sites in United States
- Volunteers
- 209 people
- Sponsor
- American Regent, Inc.
Anemia
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
- Trial name
- NCT00740246
- Testing
- VIT-45
- Where
- United States
- Volunteers
- 594 people
- Sponsor
- American Regent, Inc.