Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients

This is an interventional treatment trial for Iron-Deficiency Anemia focused on measuring Iron, Anemia, Chronic Kidney Disease, Peritoneal Dialysis, Inflammation, Oxidative stress Read More

Inclusion Criteria:

• For women of childbearing age, negative serum pregnancy test at screening.
• Severe chronic kidney disease (TFGe lower than 30 ml/min) OR end-stage kidney disease on peritoneal dialysis.
• Anaemia, as defined by haemoglobin (Hb) < 120 g/L, within 14 days prior to screening, in a patient with or without an Erythropoiesis-stimulating agent (ESA).
• Iron depletion, as defined by transferrin saturation (TSAT) < 20% and/or a ferritin assay (FERR) < 200, within 14 days prior to screening.
• If an ESA is used, stable dose over the past 60 days.

Exclusion Criteria:

• Allergy to ferumoxytol or another intravenous iron formulation.
• Administration of ferumoxytol or any other intravenous, intramuscular or oral iron formulation within 30 days of enrolment.
• Patient who have received a blood transfusion within 2 weeks prior to enrolment, or are planned to receive a blood transfusion over the duration of the study.
• Patient currently participating in a clinical trial with another investigational drug or device or who have received an investigational drug or device within 30 days of enrolment in this study.
• Hb < 90 g/L at the time of screening.
• Existing or clinically suspected bleeding of digestive, gynaecological or other origin.
• Patient who have another cause of anemia, other than iron deficiency (for example, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, multiple myeloma, myelodysplastic disorder, etc.).
• Patients who are not responding to ESA or who are receiving in excess of 30000 units/week of erythropoietin (EPO), or 150 mcg/week of darbepoietin alfa.
• Major surgery within one month prior to enrolment in the study or planned surgery, other than vascular access creation, while the patient is in on the study.
• Patient who have had a malignancy (except for non-melanoma cancer of the skin) unless the patient has received curative treatment and has been disease-free for > 2 years.
• Patient who are considered by the Investigator to have a medical status that would preclude the patient's participation in this protocol.
• Patient due to have a magnetic resonance imaging examination or in whom such an examination is planned, in the next three months.
• Woman who plans to become pregnant in the next three months.
• Woman that is breastfeeding.
• Ongoing or recent (< 2 weeks) bacterial infection requiring treatment.
• Patient unable to give informed consent.
• Patient refuses to give informed consent.