Clinical trials: Ferric Carboxymaltose
- Condition Ferric Carboxymaltose
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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.
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 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.
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
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.
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, Fibromyalgia
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia.
- Trial name
- NCT02409459
- Testing
- Injectafer
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- American Regent, Inc.
Restless Legs Syndrome (RLS)
Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)
- Trial name
- NCT01382901
- Testing
- Ferric Carboxymaltose (FCM)
- Volunteers
- 45 people
- Sponsor
- American Regent, 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
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.
Anemia
Safety and Tolerability of a Single Dose of FCM vs. 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
- NCT00704353
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 735 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 (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.
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
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 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
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, 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 Anemia
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following…
- Trial name
- NCT01307007
- Testing
- Ferric Carboxymaltose (FCM), Iron Dextran Injection
- Volunteers
- 69 people
- Sponsor
- American Regent, Inc.