Clinical trials: Ferric Carboxymaltose
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
Iron Deficiency Anemia (IDA)
A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia
The goal of this clinical trial is to see if a new intravenous iron formulation (Ferric Bepectate IV Injection) can treat adult patients with iron deficiency anemia (IDA) by increasing blood hemoglobin (Hb) as an established…
- Trial name
- NCT07687784
- Testing
- Ferric Bepectate IV Injection, Ferric Carboxymaltose Injection [Ferinject], Ferric Carboxymaltose Injection [Injectafer®]
- Where
- 13 sites in United States, Bulgaria and 2 more
- Volunteers
- 1,366 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
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.
Iron Deficiency, Anaemia
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anaemia under fasting condition.
- Trial name
- NCT06080555
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Ferinject]
- Where
- 4 sites in China
- Volunteers
- 84 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Thrombocytosis, Iron-Deficiency Anemia
Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)
The aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
- Trial name
- NCT00882414
- Testing
- FERINJECT® (Ferric carboxymaltose)
- Where
- Austria
- Volunteers
- 26 people
- Sponsor
- Vifor Pharma
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.
Iron Deficiency Anemia
To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency Anaemia
The primary objective is to demonstrate the efficacy of ferric carboxymaltose (FCM) given in a simple dosing regimen in correcting iron deficiency anaemia (IDA), by demonstrating non-inferiority to treatment with the currently…
- Trial name
- NCT03591406
- Testing
- Ferric carboxymaltose, Iron sucrose
- Where
- China
- Volunteers
- 371 people
- Sponsor
- Vifor (International) Inc.
Anemia
Clinical Tumor Anemia Registry (TAR)
The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided.
- Trial name
- TAR (NCT01795690)
- Where
- Germany
- Volunteers
- 1,018 people
- Sponsor
- iOMEDICO AG
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 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.
Iron Deficiency Anemia
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.
- Trial name
- NCT03399084
- Testing
- Ferric carboxymaltose
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Sandoz
Iron Deficiency, Chronic Heart Failure
A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.
- Trial name
- CONFIRM-HF (NCT01453608)
- Testing
- Ferinject (ferric carboxymaltose)
- Where
- 2 sites in Poland, Russia
- Volunteers
- 304 people
- Sponsor
- Vifor Pharma
Heart Failure, Iron-deficiency
Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced…
- Trial name
- HEART-FID (NCT03037931)
- Testing
- Ferric Carboxymaltose
- Where
- 345 sites in United States, Australia and 11 more
- Volunteers
- 3,065 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.
Anaemia
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the…
- Trial name
- ASAP (NCT01131624)
- Testing
- ferrous sulphate, Ferinject
- Where
- 20 sites in Australia, Germany and 3 more
- Volunteers
- 252 people
- Sponsor
- Vifor Pharma
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.
Healthy Adult
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
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
- NCT07606105
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Injectafer®]
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Chronic Heart Failure, Iron Deficiency
Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures.
- Conditions
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
- Trial name
- FAIR-HF (NCT00520780)
- Testing
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Where
- 48 sites in Argentina, Germany and 8 more
- Volunteers
- 456 people
- Sponsor
- Vifor Pharma
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.