Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (FIRST)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AMAG Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01052779

First received: January 15, 2010

Last updated: April 3, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 15, 2010

Last Updated Date

April 3, 2013

Start Date ^ICMJE

March 2010

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the safety of IV ferumoxytol compared to IV iron sucrose [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01052779 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the efficacy of ferumoxytol as compared to iron sucrose by assessing changes in hemoglobin from Baseline to Week 5 [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

Official Title ^ICMJE

Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

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 subjects with chronic kidney disease (CKD).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Iron Deficiency
Anemia
Kidney Disease

Intervention ^ICMJE

Drug: ferumoxytol
IV injection of ferumoxytol for a total cumulative dose of 1.02 g

Other Name: Feraheme
Drug: iron sucrose
IV infusion of iron sucrose for a total cumulative dose of 1.0 g

Study Arm (s)

Active Comparator: Iron Sucrose Arm
Safety and efficacy of IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD)

Intervention: Drug: iron sucrose
Active Comparator: Ferumoxytol arm
Safety and efficacy of intravenous (IV) ferumoxytol for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD).

Intervention: Drug: ferumoxytol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

162

Completion Date

April 2012

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Key Inclusion Criteria include:

Males and females ≥18 years of age
An eGFR <60 mL/min or a diagnosis of CKD (eg, nephropathy, nephritis)
Hemoglobin <11.0 g/dL
TSAT <30%
Hemodialysis subjects on maintenance dialysis for at least three months prior to screening and currently receiving dialysis three times per week
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 the study

Exclusion Criteria:

Key Exclusion Criteria include:

History of allergy to IV iron
Allergy to 2 or more classes of drugs
Female subjects 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 investigational agent not specified by this protocol during the study period
Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01052779

Other Study ID Numbers ^ICMJE

FER-CKD-201

Has Data Monitoring Committee

Responsible Party

AMAG Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

AMAG Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

William Strauss, MD, FACC

AMAG Pharmaceuticals, Inc.

Information Provided By

AMAG Pharmaceuticals, Inc.

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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