NCT01052779

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
7 countries

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2012

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

May 15, 2018

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

January 15, 2010

Results QC Date

March 26, 2018

Last Update Submit

July 18, 2023

Conditions

Iron DeficiencyAnemiaKidney Disease

Keywords

Iron deficiency anemiaChronic kidney diseaseFerahemeFerumoxytolIron sucroseIDACKDVenofer

Outcome Measures

Primary Outcomes (2)

  • Mean Change In Hemoglobin From Baseline (Day 1) To Week 5

    The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline) The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.

    Baseline (Day 1), Week 5

  • Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5

    The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).

    Baseline (Day 1) and up to Week 5

Study Arms (2)

Ferumoxytol

EXPERIMENTAL

Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

Drug: Ferumoxytol

Iron Sucrose

ACTIVE COMPARATOR

Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g. Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

Drug: Iron Sucrose

Interventions

FerumoxytolDRUG

IV Ferumoxytol

Also known as: Feraheme
Ferumoxytol
Iron SucroseDRUG

IV Iron Sucrose

Also known as: Venofer
Iron Sucrose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥18 years of age
  • An estimated glomerular filtration rate \<60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
  • Hemoglobin \<11.0 g/deciliter (dL)
  • Transferrin saturation \<30%
  • Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
  • Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study

You may not qualify if:

  • History of allergy to IV iron
  • Allergy to 2 or more classes of drugs
  • Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
  • Hemoglobin ≤7.0 g/dL
  • Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
  • Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tempe, Arizona, 85284, United States

Location

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Chula Vista, California, 91910, United States

Location

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Mountain View, California, 94041, United States

Location

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Whittier, California, 90602, United States

Location

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Augusta, Georgia, 30901, United States

Location

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Meridian, Idaho, 83642, United States

Location

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Evergreen Park, Illinois, 60805, United States

Location

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Shreveport, Louisiana, 71101, United States

Location

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Bethesda, Maryland, United States

Location

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Springfield, Massachusetts, 01107, United States

Location

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Flushing, New York, 11355, United States

Location

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Rosedale, New York, United States

Location

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Bethlehem, Pennsylvania, 18017, United States

Location

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San Antonio, Texas, 78229, United States

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Antwerp, 2020, Belgium

Location

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Antwerp, 2060, Belgium

Location

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Vancouver, British Columbia, Canada

Location

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Richmond Hill, Ontario, Canada

Location

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Montreal, Quebec, H3A 1A1, Canada

Location

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Montreal, Quebec, H4J 1C5, Canada

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Berlin, Germany

Location

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Düsseldorf, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Göttingen, Germany

Location

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Munich, Germany

Location

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Nuremberg, Germany

Location

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Passau, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bangalore, India

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nagpur, India

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Pune, India

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Katowice, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lodz, Poland

Location

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Opole, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Radom, Poland

Location

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Szczecin, Poland

Location

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Warsaw, Poland

Location

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London, United Kingdom

Location

Related Publications (3)

  • Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.

    PMID: 24639149BACKGROUND

  • Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.

    PMID: 27462400BACKGROUND

  • Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014 Apr;9(4):705-12. doi: 10.2215/CJN.05320513. Epub 2014 Jan 23.

    PMID: 24458078DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemiaKidney DiseasesAnemia, Iron-DeficiencyRenal Insufficiency, Chronic

Interventions

Ferrosoferric OxideFerric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAnemia, HypochromicRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMineralsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Results Point of Contact

Title
Medical Information
Organization
AMAG Pharmaceuticals, Inc.
CTInterest@covispharma.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 20, 2010

Study Start

March 1, 2010

Primary Completion

July 19, 2011

Study Completion

April 19, 2012

Last Updated

July 25, 2023

Results First Posted

May 15, 2018

Record last verified: 2023-07

Locations

US(14)IN(3)PL(6)GB(1)BE(2)DE(6)CA(4)