Clinical trials: Ferric Carboxymaltose
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
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 (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.
Iron Deficiency Anemia
Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol 1VIT17044
- Trial name
- NCT04269707
- Testing
- Ferric carboxymaltose
- Where
- 2 sites in United States
- Volunteers
- 7 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.
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.
Anemia, Anemia, Postpartum
Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia
The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in…
- Conditions
- Anemia, Anemia, Postpartum, Iron Deficiency Anemia of Pregnancy, Iron Deficiency Anemia Treatment
- Trial name
- NCT07648628
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- India
- Volunteers
- 200 people
- Sponsor
- ESI-PGIMSR, Basaidarapur
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.
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes
The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
The goal of this project is to assess the feasibility, clinical effectiveness, and cost-effectiveness of IV iron therapy using ferric carboxymaltose (FCM) as a treatment for pediatric patients with iron deficiency anemia (IDA) in…
- Conditions
- Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
- Trial name
- ED-Heme FCM (NCT07414199)
- Testing
- Ferric Carboxymaltose (FCM), Ferrous Sulfate
- Volunteers
- 150 people
- Sponsor
- Children's Hospital of Orange County
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.