Completed

Use of FERAHEME® (Ferumoxytol) for Severe Chronic Kidney Disease and Peritoneal Dialysis

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What is being tested

Ferumoxytol

Drug
Who is being recruted

Iron Deficiencies+19

+ Urogenital Diseases

+ Anemia

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorGeorges Ouellet
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleUse of FERAHEME® (Ferumoxytol) for Severe Chronic Kidney Disease and Peritoneal Dialysis
NCT01942460
Principal SponsorGeorges Ouellet
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Iron DeficienciesUrogenital DiseasesAnemiaAnemia, HypochromicChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsHematologic DiseasesHemic and Lymphatic DiseasesInflammationKidney DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesAnemia, Iron-DeficiencyIron Metabolism DisordersDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
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.
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17 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hôpital Maisonneuve-Rosemont

Montreal, CanadaOpen Hôpital Maisonneuve-Rosemont in Google Maps
CompletedOne Study Center