IV Iron Replacement for Anemia

(Iron-RANC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Iberia Sosa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Fox Chase Cancer Center

Must not be taking: Erythropoietin stimulating agents

Disqualifiers: Active infection, Heart failure, Angina, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using erythropoietin stimulating agents, you must not have used them within 4 weeks before the trial unless you have chronic kidney disease.

What evidence supports the effectiveness of the drug Venofer for treating anemia?

Research shows that Venofer, which contains iron sucrose, is effective in treating iron deficiency anemia, especially for patients who cannot take oral iron. It quickly increases important blood levels like hemoglobin and has been used safely for many years. ^{1 2 3 4 5}

Is IV iron sucrose safe for humans?

IV iron sucrose has been used since 1949 and is generally considered safe, with a good safety profile for treating iron deficiency anemia. However, there are concerns about potential long-term effects like oxidative stress and kidney injury, especially in patients with chronic kidney disease. ^{1 4 6 7 8}

How does IV iron sucrose differ from other anemia treatments?

IV iron sucrose is unique because it is administered directly into the bloodstream, which allows for rapid improvement in iron levels and is particularly beneficial for patients who cannot tolerate or do not respond to oral iron supplements. It is also used as a first-line treatment in certain conditions like end-stage kidney disease and chronic heart failure, offering a good safety profile and effectiveness in increasing hemoglobin and iron stores. ^{1 4 9 10 11}

Research Team

Iberia Sosa, MD

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I am receiving treatment before surgery for cancer in my breast, chest, stomach area, or urinary system.

Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion Criteria

I do not have an infection that affects my whole body.

Known hypersensitivity to Iron sucrose

Pregnant or breast feeding. Refer to section 4.4 for further detail

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous iron sucrose monotherapy and may undergo neoadjuvant chemotherapy, radiation, and immunotherapy

24 weeks

Weekly visits for iron infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hemoglobin levels and transfusion frequency

6 weeks

Treatment Details

Interventions

• Venofer (Iron Replacement)

Trial Overview 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.

Participant Groups

Group I: Venofer treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Dr. James Helstrom

Fox Chase Cancer Center

Chief Medical Officer since 2014

MD from University of Colorado School of Medicine, MBA from Washington University in St. Louis

Dr. Robert Uzzo

Fox Chase Cancer Center

Chief Executive Officer since 2022

MD from Cleveland Clinic, MBA

Findings from Research

Intravenous iron sucrose (Feronia IV) significantly increased hemoglobin levels in women with iron deficiency anemia, with an average rise of 2.43 gm% after 4 weeks of treatment across 143 analyzable cases.

The treatment was found to be safe, as no serious adverse reactions were reported, making it an effective option for managing iron deficiency anemia in gynecological and obstetric practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of intravenous iron sucrose in the management of anemia in gynecological and obstetrical practice. Dewan, B., Philipose, N., Balasubramanian, A.[2022]

A review of intravenous iron formulations from 2001-2003 found that higher molecular weight iron dextran was associated with significantly more adverse drug events (ADEs) compared to lower molecular weight iron dextran, sodium ferric gluconate complex, and iron sucrose.

The overall rate of intravenous iron-related ADEs was very low at approximately 38 per million doses, with life-threatening ADEs being much less common in non-dextran formulations, highlighting their safety profile despite the high cost of preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on adverse drug events associated with parenteral iron. Chertow, GM., Mason, PD., Vaage-Nilsen, O., et al.[2022]

Intravenous iron, particularly iron sucrose, can lead to oxidative stress and endothelial dysfunction in patients with chronic kidney disease, raising concerns about its long-term safety.

Iron sucrose infusion has been associated with acute renal injury and inflammation, as indicated by increased levels of urinary albumin and specific enzymes, suggesting a need for further investigation into the long-term effects of intravenous iron treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute injury with intravenous iron and concerns regarding long-term safety. Bishu, K., Agarwal, R.[2022]

In a study of 1500 patients undergoing maintenance haemodialysis, proactively administered high-dose iron sucrose resulted in significantly higher monthly iron doses compared to reactively administered low-dose iron sucrose, suggesting better management of iron levels.

Patients receiving high-dose iron sucrose experienced fewer adverse events related to heart issues and hospitalizations, indicating that this proactive approach may enhance safety and efficacy in treatment without increasing mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose versus low-dose iron sucrose in individuals undergoing maintenance haemodialysis: a retrospective study. Liu, L., Cheng, H., Lv, Y., et al.[2022]

A study comparing the original iron sucrose product Venofer® and the generic version AZAD (ISA) found no significant differences in bioavailability, toxicity, or stability in human cell models, indicating that ISA is comparable to Venofer® in these aspects.

The results suggest that ISA has identical physico-chemical properties and bioavailability in vitro, providing a strong foundation for future clinical trials to assess the efficacy and safety of this generic iron sucrose formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD. Praschberger, M., Cornelius, C., Schitegg, M., et al.[2018]

In a multicenter North American trial involving 77 patients with dialysis-associated anemia, iron sucrose therapy significantly increased hemoglobin levels after just three doses and maintained elevated levels for at least five weeks after the final dose.

The study found that administering 1,000 mg of iron sucrose in 10 undiluted IV doses was safe, with no serious adverse reactions or changes in blood pressure, even in patients with previous sensitivities to iron dextran or other drug allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Charytan, C., Levin, N., Al-Saloum, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Iron Sucrose: A Wealth of Experience in Treating Iron Deficiency. [2023]

2. India pubmed.ncbi.nlm.nih.gov

Assessment of intravenous iron sucrose in the management of anemia in gynecological and obstetrical practice. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

[Evaluation of the efficacy of intravenous iron III-hydroxide saccharate for treating adult patients with iron deficiency anemia]. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Oral versus intravenous iron therapy in iron deficiency anemia: An observational study. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Treatments of the martial deficiencies: preparations available in France]. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Update on adverse drug events associated with parenteral iron. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Acute injury with intravenous iron and concerns regarding long-term safety. [2022]

8. England pubmed.ncbi.nlm.nih.gov

High-dose versus low-dose iron sucrose in individuals undergoing maintenance haemodialysis: a retrospective study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Bioavailability and stability of intravenous iron sucrose originator versus generic iron sucrose AZAD. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Retrospective Safety Evaluation of a Pharmacist-Assisted Total Dose Iron Sucrose Protocol in Hospital Inpatients With Iron Deficiency Anemia. [2022]