- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01942460
Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients
April 10, 2015 updated by: Georges Ouellet
Use of FERAHEME® (Ferumoxytol) for Severe Chronic Kidney Disease and Peritoneal Dialysis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T 2M4
- Hôpital Maisonneuve-Rosemont
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ferumoxytol
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hemoglobin, serum ferritin and transferrin saturation
Time Frame: 4 weeks following ferumoxytol administration
|
4 weeks following ferumoxytol administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in inflammatory markers (C-reactive protein and Interleukin-6)
Time Frame: 60 minutes following ferumoxytol administration
|
60 minutes following ferumoxytol administration
|
Change in oxidative stress markers (Malondialdehyde, Advance Oxidation Protein Products, Non Transferrin-bound Iron)
Time Frame: 60 minutes following ferumoxytol administration
|
60 minutes following ferumoxytol administration
|
Change in soluble transferrin receptor
Time Frame: 4 weeks following ferumoxytol administration
|
4 weeks following ferumoxytol administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georges Ouellet, MD, Maisonneuve-Rosemont Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
September 6, 2013
First Submitted That Met QC Criteria
September 10, 2013
First Posted (ESTIMATE)
September 16, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 13, 2015
Last Update Submitted That Met QC Criteria
April 10, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Urologic Diseases
- Hematologic Diseases
- Renal Insufficiency
- Anemia, Hypochromic
- Iron Metabolism Disorders
- Kidney Diseases
- Renal Insufficiency, Chronic
- Inflammation
- Anemia, Iron-Deficiency
- Anemia
- Hematinics
- Pharmaceutical Solutions
- Parenteral Nutrition Solutions
- Ferrosoferric Oxide
Other Study ID Numbers
- FER-CA-IIT-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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