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

NCT01942460 | Completed Phase 4

• 1 other identifier: FER-CA-IIT-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol dose on various markers for iron stores, as well as on various markers for inflammation and oxidative stress.

Conditions

Iron-Deficiency Anemia; Inflammation; Oxidative Stress

Keywords

Iron; Anemia; Chronic Kidney Disease; Peritoneal Dialysis; Inflammation; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin, serum ferritin and transferrin saturation

  4 weeks following ferumoxytol administration

Secondary Outcomes (3)

• Change in inflammatory markers (C-reactive protein and Interleukin-6)

  60 minutes following ferumoxytol administration

• Change in oxidative stress markers (Malondialdehyde, Advance Oxidation Protein Products, Non Transferrin-bound Iron)

  60 minutes following ferumoxytol administration

• Change in soluble transferrin receptor

  4 weeks following ferumoxytol administration

Study Arms (1)

Ferumoxytol

EXPERIMENTAL

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

Also known as: Feraheme

Ferumoxytol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georges Ouellet: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Inflammation; Anemia; Renal Insufficiency, Chronic

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Georges Ouellet, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 16, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

CA (1)