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Clinical Trials/NCT01942460
NCT01942460
Completed
Phase 4

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

Georges Ouellet1 site in 1 country15 target enrollmentStarted: September 2013Last updated:
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ConditionsIron-Deficiency AnemiaInflammationOxidative Stress
InterventionsFerumoxytol
DrugsFerumoxytol

Overview

Phase
Phase 4
Status
Completed
Sponsor
Georges Ouellet
Enrollment
15
Locations
1
Primary Endpoint
Change in hemoglobin, serum ferritin and transferrin saturation
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Ferumoxytol

Experimental

Intervention: Ferumoxytol (Drug)

Outcomes

Primary Outcomes

Change in hemoglobin, serum ferritin and transferrin saturation

Time Frame: 4 weeks following ferumoxytol administration

Secondary Outcomes

  • Change in oxidative stress markers (Malondialdehyde, Advance Oxidation Protein Products, Non Transferrin-bound Iron)(60 minutes following ferumoxytol administration)
  • Change in inflammatory markers (C-reactive protein and Interleukin-6)(60 minutes following ferumoxytol administration)
  • Change in soluble transferrin receptor(4 weeks following ferumoxytol administration)

Investigators

Sponsor
Georges Ouellet
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Georges Ouellet

Nephrologist

Maisonneuve-Rosemont Hospital

Study Sites (1)

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