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Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

NCT ID: NCT01227616

Last Updated: 2022-04-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-02-28

Brief Summary

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The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

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Detailed Description

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This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for the episodic treatment of IDA in hemodialysis subjects with CKD over a 1-year period. As part of this Main Study, an Oxidative Stress Substudy and an MRI Substudy were conducted. The Oxidative Stress Substudy, to be run concurrently with the initial TP of the Main Study, was to examine the varying degrees to which iron sucrose and ferumoxytol may or may not induce oxidative stress in vitro in subjects undergoing hemodialysis. The MRI Substudy, to be run concurrently with the Main Study and continue for an additional 11 months, was to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a 2-year period.

Conditions

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Iron Deficiency Anemia Treatment Chronic Kidney Disease(CKD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ferumoxytol

Intravenous (IV) iron

Group Type EXPERIMENTAL

Ferumoxytol

Intervention Type DRUG

IV Ferumoxytol

IV Iron Sucrose

Intravenous (IV) iron

Group Type ACTIVE_COMPARATOR

Iron Sucrose

Intervention Type DRUG

IV Iron Sucrose

Interventions

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Ferumoxytol

IV Ferumoxytol

Intervention Type DRUG

Iron Sucrose

IV Iron Sucrose

Intervention Type DRUG

Other Intervention Names

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Feraheme Venofer

Eligibility Criteria

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Inclusion Criteria

1. Males and females ≥18 years of age
2. Diagnosis of CKD
3. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
4. Female subjects 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 participation in the study

Exclusion Criteria

1. History of allergy to either oral or IV iron
2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
3. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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

Pine Bluff, Arkansas, United States

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Azusa, California, United States

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Beverly Hills, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Lynwood, California, United States

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Northridge, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Gabriel, California, United States

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Simi Valley, California, United States

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Whittier, California, United States

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Whittier, California, United States

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Middlebury, Connecticut, United States

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Coral Springs, Florida, United States

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Miami, Florida, United States

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Augusta, Georgia, United States

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Macon, Georgia, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Framingham, Massachusetts, United States

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Pontiac, Michigan, United States

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Roseville, Michigan, United States

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Farmington, Missouri, United States

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Brooklyn, New York, United States

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Ridgewood, New York, United States

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The Bronx, New York, United States

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Asheville, North Carolina, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Arlington, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Montreal, , Canada

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Montreal, , Canada

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Toronto, , Canada

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London, , United Kingdom

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London, , United Kingdom

Site Status

Countries

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United States Canada United Kingdom

References

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Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z. Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial . Clin Nephrol. 2019 Apr;91(4):237-245. doi: 10.5414/CN109512.

Reference Type RESULT
PMID: 30802204 (View on PubMed)

Macdougall IC, Dahl NV, Bernard K, Li Z, Batycky A, Strauss WE. The Ferumoxytol for Anemia of CKD Trial (FACT)-a randomized controlled trial of repeated doses of ferumoxytol or iron sucrose in patients on hemodialysis: background and rationale. BMC Nephrol. 2017 Apr 3;18(1):117. doi: 10.1186/s12882-017-0523-8.

Reference Type DERIVED
PMID: 28372549 (View on PubMed)

Other Identifiers

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AMAG-FER-CKD-401

Identifier Type: -

Identifier Source: org_study_id

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