Ferric carboxymaltose
- Generic Name
- Ferric carboxymaltose
- Brand Names
- Injectafer
- Drug Type
- Small Molecule
- Chemical Formula
- -
- CAS Number
- 9007-72-1
- Unique Ingredient Identifier
- 6897GXD6OE
- Background
Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.
- Indication
Ferric carboxymaltose is an iron replacement product indicated for the treatment of iron deficiency anemia in patients ≥1 year of age who have an intolerance to, or unsatisfactory response from, oral iron therapy. It is also indicated in adult patients who have non-dialysis-dependent chronic kidney disease.
- Associated Conditions
- Iron Deficiency Anemia (IDA)
- Associated Therapies
- -
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
- Conditions
- Interventions
- First Posted Date
- 2015-05-25
- Last Posted Date
- 2021-05-11
- Lead Sponsor
- American Regent, Inc.
- Target Recruit Count
- 244
- Registration Number
- NCT02453334
- Locations
- 🇺🇸
Lakes Research, Miami Lakes, Florida, United States
🇺🇸Michiana Hematology Oncology, PC, South Bend, Indiana, United States
🇺🇸Compassionate Care Research Group, Inc., Riverside, California, United States
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
- First Posted Date
- 2015-04-06
- Last Posted Date
- 2018-02-20
- Lead Sponsor
- American Regent, Inc.
- Target Recruit Count
- 81
- Registration Number
- NCT02409459
- Locations
- 🇺🇸
Clinical Research Solutions, Franklin, Tennessee, United States
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
- First Posted Date
- 2015-03-24
- Last Posted Date
- 2021-10-12
- Lead Sponsor
- American Regent, Inc.
- Target Recruit Count
- 209
- Registration Number
- NCT02397057
- Locations
- 🇺🇸
Egret Bay Neurology, Houston, Texas, United States
🇺🇸Elite Research Institute, Miami, Florida, United States
🇺🇸The Polyclinic, Madison Center, Seattle, Washington, United States
Iron Status and Human Metabolism
- Conditions
- Interventions
- First Posted Date
- 2014-12-04
- Last Posted Date
- 2022-07-19
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 29
- Registration Number
- NCT02308449
- Locations
- 🇬🇧
University of Oxford OCMR & CCRF, John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom
A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto)
- Conditions
- Interventions
- First Posted Date
- 2014-04-29
- Last Posted Date
- 2017-07-13
- Lead Sponsor
- German Breast Group
- Target Recruit Count
- 961
- Registration Number
- NCT02125344
- Locations
- 🇩🇪
NTC, Heidelberg, Baden-Württemberg, Germany
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
- Conditions
- Interventions
- First Posted Date
- 2014-03-13
- Last Posted Date
- 2020-09-17
- Lead Sponsor
- American Regent, Inc.
- Target Recruit Count
- 198
- Registration Number
- NCT02086968
Randomized Study Comparing Ferric Carboxymaltose to Iron Sucrose to Treat Fe Deficiency in the Surgically Critically Ill
- Conditions
- Interventions
- First Posted Date
- 2013-12-12
- Last Posted Date
- 2018-01-12
- Lead Sponsor
- Denver Health and Hospital Authority
- Registration Number
- NCT02009943
- Locations
- 🇺🇸
Denver Health Medical Center, Denver, Colorado, United States
Differential Gene Expression in Patients With Heart Failure and Iron Deficiency - Effects of Ferric Carboxymaltose
- First Posted Date
- 2013-11-07
- Last Posted Date
- 2018-10-31
- Lead Sponsor
- University of Zurich
- Target Recruit Count
- 20
- Registration Number
- NCT01978028
- Locations
- 🇨🇭
University Hospital Zurich, Division of Cardiology, Zurich, ZH, Switzerland
Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting
- First Posted Date
- 2013-09-25
- Last Posted Date
- 2017-09-08
- Lead Sponsor
- American Regent, Inc.
- Target Recruit Count
- 1000
- Registration Number
- NCT01950247
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
- Conditions
- Interventions
- First Posted Date
- 2013-08-14
- Last Posted Date
- 2017-04-12
- Lead Sponsor
- National University Hospital, Singapore
- Target Recruit Count
- 50
- Registration Number
- NCT01922479
- Locations
- 🇸🇬
National University Heart Centre, Singapore, Singapore, Singapore
🇸🇬Tan Tock Seng Hospital, Singapore, Singapore
Drug Development Updates
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