What side effects are associated with this type of intervention?

Intravenous iron sucrose, used to replenish iron stores in anemic patients, commonly causes gastrointestinal disturbances like nausea, vomiting, and diarrhea. Other side effects include hypotension, dizziness, headaches, muscle cramps, and joint pain. There is also a risk of allergic reactions, ranging from mild rashes to severe anaphylactic reactions. Monitoring for these side effects is essential to ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for anemia, particularly those aimed at replenishing iron stores. Intravenous iron sucrose is one such treatment, commonly used in patients undergoing chemotherapy or with chronic kidney disease. Other similar FDA-approved intravenous iron formulations include iron dextran, ferric gluconate, and ferric carboxymaltose. These treatments are designed to quickly restore iron levels in patients who cannot tolerate or do not respond adequately to oral iron supplements. Additionally, erythropoiesis-stimulating agents (ESAs) like epoetin alfa and darbepoetin alfa are also approved for anemia management, particularly in chronic kidney disease and chemotherapy-induced anemia.

What other types of research exist?

Promising novel alternatives to intravenous iron sucrose for anemia patients include oral iron formulations with enhanced absorption, such as ferric maltol, and newer intravenous iron formulations like ferric carboxymaltose and iron isomaltoside. Additionally, research into hepcidin modulators and erythropoiesis-stimulating agents (ESAs) combined with iron supplementation is ongoing and may offer effective alternatives in the near future.

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IV Iron Replacement for Anemia (Iron-RANC Trial)

Q: What is the mechanism of action of this treatment?

Intravenous iron sucrose replenishes iron stores in the body, which is essential for the production of hemoglobin and red blood cells. This treatment is particularly important for anemia patients because it addresses iron deficiency, a common cause of anemia, and helps alleviate symptoms like fatigue and weakness. The rapid correction of iron levels through intravenous administration is especially beneficial for patients undergoing treatments such as chemotherapy, which can worsen anemia.

Phase 2

Recruiting

Led By Iberia Sosa, MD

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if giving iron through an IV can help cancer patients who are getting chemotherapy before surgery. The goal is to improve their blood health and reduce the need for blood transfusions. Intravenous iron therapy has been shown to be advantageous in treating anemia and reducing the need for blood transfusions in cancer patients.

Who is the study for?

This trial is for adults over 18 with anemia (Hgb <10.5 g/dL) during chemotherapy, low iron levels, and who are planning surgery after chemo for breast, thoracic, GI or GU cancers. They must understand and sign consent forms. Excluded are those on certain anemia drugs, with uncontrolled illnesses, recent iron infusions, pregnant/breastfeeding women, other causes of anemia or known allergy to Iron sucrose.

What is being tested?

The study tests the effectiveness of Venofer (intravenous iron sucrose) as a single therapy in reducing anemia for patients undergoing neoadjuvant chemotherapy before surgical cancer treatment. It's open-label at one institution aiming to see if this approach can improve patient outcomes.

What are the potential side effects?

Possible side effects of Venofer may include allergic reactions like itching or rash; muscle cramps; dizziness; changes in blood pressure; nausea or vomiting; headache; joint pain; fever or shivering.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from baseline to highest Hgb value

Secondary study objectives

Number of transfusions during neo-adjuvant period

Side effects data

From 2004 Phase 3 trial • 182 Patients • NCT00236977

Dysgeusia

Oedema peripheral

Diarrhea NOS

Constipation

Dizziness

Hypertension NOS

Nausea

Oedema NOS

Fatigue

Vomiting NOS

Fecal Occult Blood Positive

Hypotension NOS

Respiratory failure

Renal failure acute

Sepsis NOS

Fluid Overload

Mental status changes

Pleural effusion

Intraoperative haemorrhage

Lobar pneumonia NOS

Urinary Tract Infection NOS

Hyponatraemia

Angina pectoris

Dyspnea

Flank pain

100%

80%

60%

40%

20%

Study treatment Arm

Venofer

Ferrous Sulfate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venofer treatmentExperimental Treatment1 Intervention

Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venofer

2003

Completed Phase 4

~290

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous iron sucrose replenishes iron stores in the body, which is essential for the production of hemoglobin and red blood cells. This treatment is particularly important for anemia patients because it addresses iron deficiency, a common cause of anemia, and helps alleviate symptoms like fatigue and weakness. The rapid correction of iron levels through intravenous administration is especially beneficial for patients undergoing treatments such as chemotherapy, which can worsen anemia.