#1 Clinical Trials Search in Europe

Ferric Carboxymaltose

Ferric carboxymaltose is an intravenous iron preparation being studied in clinical trials for treating iron deficiency and anemia in various patient populations. These trials aim to evaluate its effectiveness, safety, and impact on quality of life across conditions like heart failure, cancer, and iron deficiency anemia. The studies examine how ferric carboxymaltose affects blood iron levels, hemoglobin, and other health outcomes compared to placebo or standard treatments.

Table of Contents

What is Ferric Carboxymaltose?

Ferric Carboxymaltose (FCM) is an intravenous (IV) iron replacement medication used to treat iron deficiency anemia. It is also known by brand names such as Ferinject® or Injectafer®[1][2]. FCM is designed to quickly and effectively replenish iron stores in the body, helping to improve symptoms associated with iron deficiency.

Conditions Treated with Ferric Carboxymaltose

Ferric Carboxymaltose is used to treat various conditions associated with iron deficiency, including:

  • Iron Deficiency Anemia (IDA): This is the primary condition for which FCM is prescribed. IDA occurs when the body doesn’t have enough iron to produce healthy red blood cells[3].
  • Heart Failure: FCM has shown benefits in patients with heart failure, particularly those with reduced ejection fraction (HFrEF). This means the heart is not pumping blood as effectively as it should[2][4].
  • Cancer-related Anemia: Patients undergoing chemotherapy for colorectal cancer or multiple myeloma often experience anemia, which can be treated with FCM[5][6].
  • Postoperative Anemia: FCM may be used to treat anemia in patients recovering from surgery, such as hip fracture repair[7].

How Ferric Carboxymaltose Works

Ferric Carboxymaltose works by rapidly delivering iron directly into the bloodstream. Once in the body, the iron is used to produce hemoglobin, a protein in red blood cells that carries oxygen throughout the body. By increasing hemoglobin levels, FCM helps improve symptoms of anemia such as fatigue, weakness, and shortness of breath[3].

How Ferric Carboxymaltose is Administered

Ferric Carboxymaltose is given as an intravenous (IV) injection or infusion. The dosage and administration schedule can vary depending on the patient’s condition and iron deficiency severity. Some key points about FCM administration include:

  • It’s typically given as a single dose or two doses separated by a week[5].
  • The infusion usually takes about 15-20 minutes[7].
  • Doses can range from 500 mg to 2000 mg of iron, depending on the patient’s needs[5].
  • FCM can be administered alongside chemotherapy in cancer patients[8].

Benefits of Ferric Carboxymaltose

Ferric Carboxymaltose offers several advantages over other iron replacement therapies:

  • Rapid Iron Replenishment: FCM can quickly restore iron levels, often leading to improvements in hemoglobin within a few weeks[3].
  • Fewer Infusions: Compared to some other IV iron treatments, FCM often requires fewer infusions to achieve the desired iron levels[5].
  • Improved Quality of Life: By treating anemia, FCM can help reduce fatigue and improve overall quality of life in patients with various conditions[5].
  • Heart Function Benefits: In patients with heart failure, FCM may help improve heart function and reduce hospitalizations[4].

Ongoing Research and Clinical Trials

Researchers continue to study Ferric Carboxymaltose to understand its full potential. Some areas of ongoing research include:

  • Heart Failure Treatment: Studies are investigating how FCM affects heart function and structure in patients with heart failure[4].
  • Cancer-related Anemia: Researchers are exploring the benefits of FCM in different types of cancer patients undergoing chemotherapy[8].
  • Pediatric Use: Clinical trials are assessing the safety and effectiveness of FCM in infants and children with iron deficiency anemia[9].
  • Postoperative Recovery: Studies are examining how FCM might improve outcomes in patients recovering from surgery[7].

Potential Side Effects and Safety

While Ferric Carboxymaltose is generally well-tolerated, like all medications, it can cause side effects. Common side effects may include:

  • Headache
  • Nausea
  • Injection site reactions (such as pain or bruising)
  • Temporary changes in blood pressure

Serious side effects are rare but can include allergic reactions. It’s important to receive FCM in a healthcare setting where you can be monitored during and shortly after the infusion[9].

Always discuss potential risks and benefits with your healthcare provider before starting any new treatment.

Aspect Details
Drug Name Ferric Carboxymaltose (also known as Ferinject, Injectafer)
Administration Intravenous infusion, typically 15-20 minutes
Conditions Studied Iron deficiency anemia, heart failure, cancer-related anemia, iron deficiency in infants
Primary Outcomes Changes in hemoglobin, serum iron parameters, quality of life, exercise capacity
Safety Profile Generally well-tolerated; monitoring for adverse events in trials
Unique Features Allows higher doses of iron in a single infusion compared to other IV iron formulations
Ongoing Research Bioequivalence studies, effects on cardiac function, use in various patient populations

FAQ

  • What is ferric carboxymaltose? Ferric carboxymaltose is an intravenous iron preparation used to treat iron deficiency anemia. It allows for higher doses of iron to be given in a single infusion compared to other IV iron formulations.
  • What conditions is ferric carboxymaltose being studied for? Clinical trials are evaluating ferric carboxymaltose for conditions like iron deficiency anemia, heart failure with reduced ejection fraction, anemia in cancer patients, and iron deficiency in infants.
  • How is ferric carboxymaltose administered? Ferric carboxymaltose is given as an intravenous infusion, typically over 15-20 minutes. Dosing is based on the patient's weight and hemoglobin levels.
  • What are the main outcomes being measured in these trials? Key outcomes include changes in hemoglobin levels, serum iron parameters, quality of life measures, exercise capacity, and cardiac function in heart failure patients.
  • Are there any safety concerns with ferric carboxymaltose? The trials are monitoring for adverse events, but ferric carboxymaltose is generally well-tolerated. Common side effects may include headache, nausea, and injection site reactions.

Ongoing Clinical Trials on Ferric Carboxymaltose

  • A Study of Intravenous Ferric Carboxymaltose on Quality of Life in Older Adults with Acute Coronary Syndrome and Iron Deficiency

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • A Study of Ferric Carboxymaltose to Improve Exercise Ability in Patients with Pulmonary Hypertension and Iron Deficiency

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on Vitamin D and Oral Iron for Patients with Chronic Heart Failure and Iron Deficiency

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effects of Ferric Carboxymaltose on Heart Health and Quality of Life in Patients with Recent Heart Attack and Iron Deficiency

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on Treating Anemia After Cesarean with Ferric Carboxymaltose or Oral Iron in Women with Moderate Iron Deficiency Anemia

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Intravenous ferric carboxymaltose for drug‑resistant restless legs syndrome: a randomized delayed‑start trial in adults

    Not yet recruiting

    1 1 1
    Investigated drugs:
    France

  • Study on Preoperative Iron Infusion with Ferric Carboxymaltose for Patients with Stomach Cancer

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study on Iron Infusion with Ferric Carboxymaltose for Elderly Patients with Severe Aortic Stenosis and Iron Deficiency Undergoing TAVI

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Intravenous Ferric Carboxymaltose for Preoperative Anemia in Patients with Lower Limb Peripheral Artery Disease

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Anemia: A condition where you don't have enough healthy red blood cells to carry adequate oxygen to your body's tissues, often causing fatigue and weakness.
  • Ferritin: A blood protein that contains iron and is the primary form of iron stored inside cells.
  • Hemoglobin: The protein in red blood cells that carries oxygen throughout the body. It's measured to diagnose anemia.
  • Iron deficiency: A condition where the body doesn't have enough iron to produce hemoglobin, often leading to anemia.
  • Transferrin saturation: A blood test that measures how much iron is bound to transferrin, a protein that transports iron in the blood.
  • Ejection fraction: A measurement of how much blood the left ventricle pumps out with each contraction, used to assess heart function.
  • Cardiac resynchronization therapy: A treatment for heart failure that uses a special pacemaker to coordinate the heart's contractions.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Bioequivalence: When two medications have the same active ingredient and produce the same effect in the body at the same dose.
  • Erythropoiesis: The process of producing red blood cells in the body.

References

  1. https://clinicaltrials.gov/study/NCT06080555
  2. https://clinicaltrials.gov/study/NCT03380520
  3. https://clinicaltrials.gov/study/NCT03399084
  4. https://clinicaltrials.gov/study/NCT03871699
  5. https://clinicaltrials.gov/study/NCT02469480
  6. https://clinicaltrials.gov/study/NCT01100879
  7. https://clinicaltrials.gov/study/NCT06080893
  8. https://clinicaltrials.gov/study/NCT01101399
  9. https://clinicaltrials.gov/study/NCT04968379