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

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ClinicalTrials.gov Identifier: NCT01942460
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Georges Ouellet, Maisonneuve-Rosemont Hospital

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.

Condition or disease Intervention/treatment Phase
Iron-Deficiency Anemia Inflammation Oxidative Stress Drug: Ferumoxytol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of FERAHEME® (Ferumoxytol) for Severe Chronic Kidney Disease and Peritoneal Dialysis
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: Ferumoxytol Drug: Ferumoxytol
Other Name: Feraheme




Primary Outcome Measures :
  1. Change in hemoglobin, serum ferritin and transferrin saturation [ Time Frame: 4 weeks following ferumoxytol administration ]

Secondary Outcome Measures :
  1. Change in inflammatory markers (C-reactive protein and Interleukin-6) [ Time Frame: 60 minutes following ferumoxytol administration ]
  2. Change in oxidative stress markers (Malondialdehyde, Advance Oxidation Protein Products, Non Transferrin-bound Iron) [ Time Frame: 60 minutes following ferumoxytol administration ]
  3. Change in soluble transferrin receptor [ Time Frame: 4 weeks following ferumoxytol administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942460


Locations
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Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Georges Ouellet
Investigators
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Principal Investigator: Georges Ouellet, MD Hôpital Maisonneuve-Rosemont

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Responsible Party: Georges Ouellet, Nephrologist, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01942460    
Other Study ID Numbers: FER-CA-IIT-001
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by Georges Ouellet, Maisonneuve-Rosemont Hospital:
Iron
Anemia
Chronic Kidney Disease
Peritoneal Dialysis
Inflammation
Oxidative stress
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Anemia, Iron-Deficiency
Inflammation
Pathologic Processes
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions