Iron Deficiency Anemia TreatmentPhase 4NCT01227616

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

A Phase 4 study testing Ferumoxytol and Iron Sucrose in people with Iron Deficiency Anemia Treatment and Chronic Kidney Disease(CKD), run by AMAG Pharmaceuticals, Inc. at 43 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
What is being tested?: Ferumoxytol and Iron Sucrose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 296 participants
Where: 43 sitesin 3 countries
Study dates: Aug 2013to Feb 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

43 sites in 3 countries.

Country

City, postcode or hospital

43 sites in 3 countries

United States38 sites

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
Arlington, Texas, 76015
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Asheville, North Carolina, 28805
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Augusta, Georgia, 30904
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Azusa, California, 91702
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Bethlehem, Pennsylvania, 18017
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Beverly Hills, California, 90211
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Brooklyn, New York, 11212
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Columbia, South Carolina, 29209
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Coral Springs, Florida, 33071
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Edinburg, Texas, 78539
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Farmington, Missouri, 63640
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Framingham, Massachusetts, 01702
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Houston, Texas, 78238
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Los Angeles, California, 90022
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Los Angeles, California, 90095
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Louisville, Kentucky, 40292
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Lynwood, California, 90262
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Macon, Georgia, 31217
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Miami, Florida, 33186
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Middlebury, Connecticut, 06762
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New Orleans, Louisiana, 70112
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Northridge, California, 91324
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Paramount, California, 90723
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Philadelphia, Pennsylvania, 19144
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Pine Bluff, Arkansas, 71603
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Pontiac, Michigan, 48341
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Ridgewood, New York, 11385
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Roseville, Michigan, 48066
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Sacramento, California, 95815
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San Antonio, Texas, 78205
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San Antonio, Texas, 78229
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San Diego, California, 92123
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San Gabriel, California, 91776
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Shreveport, Louisiana, 71103
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Simi Valley, California, 93065
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The Bronx, New York, 10641
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Whittier, California, 90603
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Whittier, California, 90603

Other trials in United States

Canada3 sites

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Montreal
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Montreal
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Toronto

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United Kingdom2 sites

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
London
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London

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About this study

Official title: 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

Read the detailed description

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: Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
Being tested: Ferumoxytol, Iron Sucrose
Keywords: Iron deficiency anemia (IDA), chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI), ferumoxytol, Feraheme
Medical subject headings: Renal Insufficiency, Chronic, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FerumoxytolDrug
Also called Feraheme
IV Ferumoxytol
Iron SucroseDrug
Also called Venofer
IV Iron Sucrose

Study groups in NCT01227616
Study group	Role	What they receive
Ferumoxytol	Experimental	Intravenous (IV) iron Receives: Drug: Ferumoxytol
IV Iron Sucrose	Active comparator	Intravenous (IV) iron Receives: Drug: Iron Sucrose

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Changes in Transferrin Saturation (TSAT)
Mean change in TSAT from TP Baseline to Week 5 for each TP
Measured: 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
The proportion of subjects by group achieving a ≥1.0 g/dL increase in hemoglobin at any point during each 5-week treatment period.
Measured: Up to 6 treatment periods (5 weeks per treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Feb 2017

First posted25 Oct 2010 (estimated)
Study startAug 2013
Primary completionFeb 2016
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227616
Sponsor's protocol ID: AMAG-FER-CKD-401
Status last verified: Mar 2022
First submitted: 22 Oct 2010
Last updated: 21 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30802204
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.
PubMed 28372549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Recruiting
Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Iron Deficiency Anemia Treatment
Not yet recruiting
Menstruation and Anemia Research: A Community Health Study
Anemia

All Iron Deficiency Anemia Treatment trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01227616
Acronym / sponsor ID: AMAG-FER-CKD-401
Conditions: Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
Keywords: Iron deficiency anemia (IDA), chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI), ferumoxytol, Feraheme
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 296 participants (actual)
Lead sponsor: AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2013 (actual)
Primary completion: Feb 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 19 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ferumoxytol	Experimental	Drug: FerumoxytolIntravenous (IV) iron
IV Iron Sucrose	Active comparator	Drug: Iron SucroseIntravenous (IV) iron

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FerumoxytolAlso: FerahemeIV Ferumoxytol	Drug	Ferumoxytol
Iron SucroseAlso: VenoferIV Iron Sucrose	Drug	IV Iron Sucrose

Primary outcome

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

2 secondary outcomes

Changes in Transferrin Saturation (TSAT)
Time frame: 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
Time frame: Up to 6 treatment periods (5 weeks per treatment period)

Results and safety

Results posted to the registry on 19 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ferumoxytol	196	142
Iron Sucrose	97	74

Primary outcome: Hemoglobin Changes

Time frame: Up to 6 treatment periods (5 weeks per treatment period). Mean (Standard Deviation). Unit: g/dL

Measure	Ferumoxytol n = 196	Iron Sucrose n = 97
TP1	0.5 (0.97)	0.4 (0.97)
TP2	0.6 (0.96)	0.3 (1.03)
TP3	0.6 (1.10)	0.4 (0.87)
TP4	0.5 (1.12)	0.6 (1.11)
TP5	0.4 (1.14)	0.3 (0.96)
TP6	0.5 (1.21)	-0.3 (1.00)

Ferumoxytol: Mean Difference (Final Values): 0.5, p <0.05, ANCOVA

Population analysed: Mean Change in Hemoglobin at Week 5 - ITT Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported Adverse Events (AEs) include events starting on or after day 0 up to 13 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ferumoxytol	93 of 196 (47.4%)	158 of 196 (80.6%)	16 of 196
Iron Sucrose	49 of 97 (50.5%)	81 of 97 (83.5%)	6 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30802204Macdougall 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.
Derived from this study: PubMed 28372549Macdougall 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.

Related trials for Iron Deficiency Anemia Treatment

Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
Recruiting
Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
Iron Deficiency Anemia Treatment
Not yet recruiting
Menstruation and Anemia Research: A Community Health Study
Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

43 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferumoxytol and Iron Sucrose in people with Iron Deficiency Anemia Treatment and Chronic Kidney Disease(CKD), run by AMAG Pharmaceuticals, Inc. at 43 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin Changes (time frame: Up to 6 treatment periods (5 weeks per treatment period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227616, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.