NCT01227616|CompletedPhase 4Results

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

Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for Treatment of IDA in CKD Patients on Hemodialysis

AMAG Pharmaceuticals, Inc.ClinicalTrials.gov

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1 other identifier

AMAG-FER-CKD-401

Study Type

interventional

Target

296

Locations

3 countries

Sites

Timeline

RegisteredOct 2010

StartedAug 2013

CompletionFeb 2017

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

296

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2013

Longer than P75 for phase_4

Geographic Reach

3 countries

43 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

3.5 years study duration

First Submitted

Initial submission to the registry

October 22, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed

2.8 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2019

Completed

Last Updated

April 21, 2022

Status Verified

March 1, 2022

Enrollment Period

2.5 years

First QC Date

October 22, 2010

Results QC Date

May 23, 2019

Last Update Submit

March 31, 2022

Conditions

Iron Deficiency Anemia Treatment Chronic Kidney Disease(CKD)

Keywords

Iron deficiency anemia (IDA)chronic kidney disease (CKD)hemodialysismagnetic resonance imaging (MRI)ferumoxytolFeraheme

Outcome Measures

Primary Outcomes (1)

Hemoglobin Changes
Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.
Up to 6 treatment periods (5 weeks per treatment period)

Secondary Outcomes (2)

Changes in Transferrin Saturation (TSAT)
Up to 6 treatment periods (5 weeks per treatment period)
Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP
Up to 6 treatment periods (5 weeks per treatment period)

Study Arms (2)

Ferumoxytol

EXPERIMENTAL

Intravenous (IV) iron

Drug: Ferumoxytol

IV Iron Sucrose

ACTIVE COMPARATOR

Intravenous (IV) iron

Drug: Iron Sucrose

Interventions

FerumoxytolDRUG

IV Ferumoxytol

Also known as: Feraheme

Ferumoxytol

Iron SucroseDRUG

IV Iron Sucrose

Also known as: Venofer

IV 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
Diagnosis of CKD
Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
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

You may not qualify if:

History of allergy to either oral or IV iron
Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
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

Contact the study team to confirm eligibility.