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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR SODIUM FERRIC GLUCONATE COMPLEX


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All Clinical Trials for Sodium Ferric Gluconate Complex

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00223938 ↗ Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients. Terminated Sanofi Phase 4 2003-12-30 This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
NCT00223938 ↗ Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients. Terminated Watson Pharmaceuticals Phase 4 2003-12-30 This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
NCT00354692 ↗ Effect of Two Iron Preparations on Protein in the Urine Completed Watson Pharmaceuticals Phase 4 2006-06-01 This pilot study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein
NCT00534144 ↗ Comparison Between Effects of Two Iron Preparations on Protein in the Urine Completed Watson Pharmaceuticals Phase 1 2007-09-01 This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein
NCT00661999 ↗ Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer Completed National Cancer Institute (NCI) Phase 3 2006-01-01 RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy. PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
NCT00661999 ↗ Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer Completed Mayo Clinic Phase 3 2006-01-01 RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy. PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Ferric Gluconate Complex

Condition Name

Condition Name for Sodium Ferric Gluconate Complex
Intervention Trials
Anemia 4
Anemia, Iron-Deficiency 2
Heart Failure 2
Kidney Failure, Chronic 2
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Condition MeSH

Condition MeSH for Sodium Ferric Gluconate Complex
Intervention Trials
Anemia, Iron-Deficiency 4
Heart Failure 2
Renal Insufficiency 2
Kidney Failure, Chronic 2
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Clinical Trial Locations for Sodium Ferric Gluconate Complex

Trials by Country

Trials by Country for Sodium Ferric Gluconate Complex
Location Trials
United States 20
Israel 3
Puerto Rico 1
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Trials by US State

Trials by US State for Sodium Ferric Gluconate Complex
Location Trials
California 3
Arizona 2
Louisiana 2
North Carolina 2
Florida 2
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Clinical Trial Progress for Sodium Ferric Gluconate Complex

Clinical Trial Phase

Clinical Trial Phase for Sodium Ferric Gluconate Complex
Clinical Trial Phase Trials
Phase 4 6
Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Sodium Ferric Gluconate Complex
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Sodium Ferric Gluconate Complex

Sponsor Name

Sponsor Name for Sodium Ferric Gluconate Complex
Sponsor Trials
Watson Pharmaceuticals 3
Rambam Health Care Campus 2
Sanofi 1
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Sponsor Type

Sponsor Type for Sodium Ferric Gluconate Complex
Sponsor Trials
Other 7
Industry 4
NIH 1
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Sodium Ferric Gluconate Complex: Clinical Trials, Market Analysis, and Projections

Introduction

Sodium ferric gluconate complex, commonly known by its brand name Ferrlecit, is an intravenous iron replacement therapy used primarily for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD) undergoing hemodialysis. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy in Hemodialysis Patients

Clinical trials have consistently shown that sodium ferric gluconate complex is safe and effective in managing iron deficiency anemia in hemodialysis patients. A multicenter, randomized clinical study demonstrated that high-dose intravenous treatment with 1.0 g of sodium ferric gluconate complex resulted in significant improvements in hemoglobin, hematocrit, iron saturation, and serum ferritin levels compared to low-dose intravenous treatment or oral iron therapy[1].

Safety Profile

The safety profile of sodium ferric gluconate complex has been favorable. In the aforementioned study, 83 out of 88 patients completed the treatment without significant adverse events linked to the drug. The few discontinuations were due to personal reasons or minor side effects such as rash, nausea, and chest pain with pruritus[1].

Use in Heart Failure Patients

A recent prospective, single-blind, randomized controlled trial explored the use of intravenous sodium ferric gluconate complex in patients with heart failure and iron deficiency. Although the study was cut short due to COVID-19, preliminary results indicated that IV sodium ferric gluconate complex was safe and potentially beneficial in improving exercise ability and reducing hospitalizations in this patient population[3].

Market Analysis

Current Market Position

Sodium ferric gluconate complex, marketed as Ferrlecit, holds a significant position in the intravenous iron therapy market. It is widely used in the treatment of iron deficiency anemia in patients with CKD undergoing hemodialysis. The drug's stability, safety profile, and efficacy have contributed to its popularity among healthcare providers.

Market Size and Growth

The global intravenous iron drugs market is growing, driven by the increasing prevalence of chronic kidney disease and other conditions leading to iron deficiency anemia. Sodium ferric gluconate complex is one of the key players in this market, with a steady demand due to its established efficacy and safety.

Competitive Landscape

The intravenous iron market is competitive, with other products such as iron sucrose, iron dextran, and ferumoxytol. However, sodium ferric gluconate complex has a strong foothold due to its long-standing presence and positive clinical outcomes. The market competition is expected to remain intense, with ongoing research and development aimed at improving existing therapies and introducing new ones.

Market Projections

Future Demand

The demand for sodium ferric gluconate complex is expected to continue growing as the prevalence of CKD and other conditions requiring iron replacement therapy increases. Advances in healthcare infrastructure and increased awareness of iron deficiency anemia are also likely to drive market growth.

Emerging Markets

Emerging markets, particularly in regions with growing healthcare sectors, are expected to contribute significantly to the future growth of the intravenous iron therapy market. As healthcare access improves in these regions, the demand for effective treatments like sodium ferric gluconate complex is anticipated to rise.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. The National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines, which recommend parenteral iron supplementation for hemodialysis patients with low serum ferritin and transferrin saturation, support the continued use of sodium ferric gluconate complex[1].

Pharmacological and Chemical Properties

Chemical Structure

Sodium ferric gluconate complex is a stable macromolecular complex with an apparent molecular weight of 289,000 – 440,000 daltons. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate[2][5].

Mechanism of Action

The drug works by replenishing the body's iron stores, which is essential for the production of hemoglobin and the maintenance of healthy red blood cells. This is particularly crucial for patients undergoing hemodialysis who often experience iron deficiency due to blood loss and other factors[5].

Key Takeaways

  • Efficacy and Safety: Sodium ferric gluconate complex has been proven safe and effective in treating iron deficiency anemia in hemodialysis patients.
  • Market Position: The drug holds a significant position in the intravenous iron therapy market due to its established efficacy and safety profile.
  • Future Growth: The market demand is expected to grow driven by increasing prevalence of CKD and other conditions requiring iron replacement therapy.
  • Regulatory Support: Guidelines from organizations like NKF-DOQI support the use of parenteral iron supplementation, including sodium ferric gluconate complex.

FAQs

Q: What is the primary indication for sodium ferric gluconate complex?

A: The primary indication is the treatment of iron deficiency anemia in adult and pediatric patients (aged 6 years and older) with chronic kidney disease receiving hemodialysis and supplemental epoetin therapy[5].

Q: How is sodium ferric gluconate complex administered?

A: It is administered intravenously, typically over several dialysis sessions[1].

Q: What are the common side effects of sodium ferric gluconate complex?

A: Common side effects are generally mild and include rash, nausea, and chest pain with pruritus[1].

Q: Has sodium ferric gluconate complex been studied in patients with heart failure?

A: Yes, a recent study explored its use in patients with heart failure and iron deficiency, though the study was cut short due to COVID-19[3].

Q: What is the molecular structure of sodium ferric gluconate complex?

A: It is a stable macromolecular complex with an apparent molecular weight of 289,000 – 440,000 daltons, composed of iron (III) oxide hydrate bonded to sucrose and gluconate[2][5].

Sources

  1. Sodium ferric gluconate complex in sucrose is safe and effective in the management of iron-deficiency anemia in severely iron-deficient and anemic hemodialysis patients receiving rHuEPO. PubMed.
  2. Ferrlecit (sodium ferric gluconate complex in sucrose injection). FDA.
  3. IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency and Heart Failure. PubMed.
  4. Sodium Ferric Gluconate Complex. Patsnap.
  5. Sodium ferric gluconate complex. DrugBank.

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