Iron Deficiency Anemia (IDA)Phase 4NCT01950247

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron

A Phase 4 study testing Injectafer and SOC in people with Iron Deficiency Anemia (IDA), run by American Regent, Inc..

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron Deficiency Anemia (IDA)
What is being tested?: Injectafer and SOC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,025 participants
Where: No sites listed yet
Study dates: 15 Aug 2013to Jun 2015
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

Male or female subjects ≥ 18 years of age and able to give informed consent.
Iron deficiency is the primary etiology of anemia.
If using erythropoiesis stimulating agent (ESA), the subject must be using a dose consistent with package insert that has been stable for at least 30 days.
Doses of potential myelosuppressive medications have been stable for at least 30 days.
Females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing.

Who cannot join

Hypersensitivity reaction to any component of Injectafer.
Requires dialysis for treatment of chronic kidney disease (CKD).
No evidence of iron deficiency.
During the 10 day period prior to screening has been treated with intravenous iron.
During the 30 day period prior to screening has been treated with a red red blood cell transfusion.
Any non-viral infection.

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Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months, or for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status greater than 1.
Pregnant or actively trying to become pregnant (a definitive negative result on a serum or urine pregnancy test performed on the first day of dosing will be required for study enrollment by any women of childbearing potential).
Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.

About this study

Official title: Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and Compare the Safety, Effect on QOL and Resource Utilization, of Injectafer® vs. IV Iron Standard of Care for the Treatment of IDA in an Infusion Center

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Read the detailed description

Conditions: Iron Deficiency Anemia (IDA)
Being tested: Injectafer, SOC
Medical subject headings: Anemia, Iron-Deficiency

What participants receive

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

InjectaferDrug
Also called Ferric Carboxymaltose (FCM)
2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.
SOCDrug
Also called IV Iron Standard of Care

Study groups in NCT01950247
Study group	Role	What they receive
Injectafer	Experimental	2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. Receives: Drug: Injectafer
IV Iron Standard of Care (SOC)	Active comparator	At a dose and administration regimen as determined by the study site investigator Receives: Drug: SOC

What is being measured

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

Multidimensional Assessment of Fatigue (MAF) Scores
The MAF scale has 16 items that measure the Global Fatigue Index (GFI), a composite score of Items 1 through 15. Items 1 through 14 were measured on a scale of 1 to 10, with 1 = not at all and 10 = a great deal. Items 15 and 16 had categorical responses: degree of agreement from 0 to 4, with 0=no days and 4=every day. Then, a Global Fatigue Index (GFI) is calculated by summing specific items and averaging others. The final GFI score ranges from 1 (no fatigue) to 50 (severe fatigue). The resulting score is given as the mean value.
Measured: Baseline to Day 30
Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
The WPAI consisted of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working using a scale of 0 to 10, with 0 = PROBLEM had no effect on my work and 10 = PROBLEM completely prevented me from working; 6 = degree health affected productivity in regular unpaid activities using a scale of 0 to 10, with 0 = PROBLEM had no effect on my daily activities and 10 = PROBLEM completely prevented me from doing my daily activities. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Measured: Baseline and Day 30
Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores
Participants rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as ([{sum of item 1 to 3} - 3]/18)*100; if 1 question (Q) was missing: ([{sum of item 1 to 3} -2]/12)*100. Side-effect measured as if item 4=No, score=100; if not then ([{sum of item 5 to 8} -4]/16)*100; if 1 Q was missing: ([{sum of item 5 to 8} -3]/12)*100. Convenience measured as ([{sum of item 9 to 11} -3]/18)*100; if 1 Q was missing: ([{sum of item 9 to 11} - 2]/12)*100. Global satisfaction as ([{sum of item 12 to 14} -3]/14)*100; if item 12 or 13 was missing: ([{sum of item 12 to 14} -2]/10)*100; if item 14 was missing: ([{sum of item 12 and 13} -2]/8)*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score equals greater satisfaction
Measured: Baseline and Day 30
Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores.
The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome. The overall scale and sub-scales were calculated with the standard SF-12 formulas.
Measured: Baseline and Day 30

Timeline

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

15 Aug 2013Jun 2015

First posted25 Sep 2013 (estimated)
Study start15 Aug 2013
Primary completion20 May 2015
Study completionJun 2015

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.
Other trials for Iron Deficiency Anemia (IDA)Studies 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: 1,025 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01950247
Sponsor's protocol ID: 1VIT13032
Status last verified: Nov 2024
First submitted: 23 Sep 2013
Last updated: 22 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

Official record

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All Iron Deficiency Anemia (IDA) trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and Compare the Safety, Effect on QOL and Resource Utilization, of Injectafer® vs. IV Iron Standard of Care for the Treatment of IDA in an Infusion Center
ClinicalTrials.gov ID: NCT01950247
Acronym / sponsor ID: 1VIT13032
Conditions: Iron Deficiency Anemia (IDA)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,025 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: 15 Aug 2013 (actual)
Primary completion: 20 May 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 25 Sep 2013 (estimated)
Results: Posted 22 May 2025

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
Injectafer	Experimental	Drug: Injectafer2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.
IV Iron Standard of Care (SOC)	Active comparator	Drug: SOCAt a dose and administration regimen as determined by the study site investigator

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female subjects ≥ 18 years of age and able to give informed consent.
Iron deficiency is the primary etiology of anemia.
If using erythropoiesis stimulating agent (ESA), the subject must be using a dose consistent with package insert that has been stable for at least 30 days.
Doses of potential myelosuppressive medications have been stable for at least 30 days.
Females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing.

Key exclusion criteria (13 listed)

Hypersensitivity reaction to any component of Injectafer.
Requires dialysis for treatment of chronic kidney disease (CKD).
No evidence of iron deficiency.
During the 10 day period prior to screening has been treated with intravenous iron.
During the 30 day period prior to screening has been treated with a red red blood cell transfusion.

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
InjectaferAlso: Ferric Carboxymaltose (FCM)2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.	Drug	Injectafer
SOCAlso: IV Iron Standard of Care	Drug	IV Iron Standard of Care (SOC)

Primary outcome

Multidimensional Assessment of Fatigue (MAF) Scores
Time frame: Baseline to Day 30
The MAF scale has 16 items that measure the Global Fatigue Index (GFI), a composite score of Items 1 through 15. Items 1 through 14 were measured on a scale of 1 to 10, with 1 = not at all and 10 = a great deal. Items 15 and 16 had categorical responses: degree of agreement from 0 to 4, with 0=no days and 4=every day. Then, a Global Fatigue Index (GFI) is calculated by summing specific items and averaging others. The final GFI score ranges from 1 (no fatigue) to 50 (severe fatigue). The resulting score is given as the mean value.
Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
Time frame: Baseline and Day 30
The WPAI consisted of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working using a scale of 0 to 10, with 0 = PROBLEM had no effect on my work and 10 = PROBLEM completely prevented me from working; 6 = degree health affected productivity in regular unpaid activities using a scale of 0 to 10, with 0 = PROBLEM had no effect on my daily activities and 10 = PROBLEM completely prevented me from doing my daily activities. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores
Time frame: Baseline and Day 30
Participants rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as ([{sum of item 1 to 3} - 3]/18)*100; if 1 question (Q) was missing: ([{sum of item 1 to 3} -2]/12)*100. Side-effect measured as if item 4=No, score=100; if not then ([{sum of item 5 to 8} -4]/16)*100; if 1 Q was missing: ([{sum of item 5 to 8} -3]/12)*100. Convenience measured as ([{sum of item 9 to 11} -3]/18)*100; if 1 Q was missing: ([{sum of item 9 to 11} - 2]/12)*100. Global satisfaction as ([{sum of item 12 to 14} -3]/14)*100; if item 12 or 13 was missing: ([{sum of item 12 to 14} -2]/10)*100; if item 14 was missing: ([{sum of item 12 and 13} -2]/8)*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score equals greater satisfaction
Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores.
Time frame: Baseline and Day 30
The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome. The overall scale and sub-scales were calculated with the standard SF-12 formulas.

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Iron Standard of Care (SOC)	512	455
Injectafer	513	467

Primary outcome: Multidimensional Assessment of Fatigue (MAF) Scores

Time frame: Baseline to Day 30. Mean (Standard Deviation). Unit: units on a scale

Measure	Injectafer n = 264	IV Iron Standard of Care (SOC) n = 269
Value	-8.8 (11.38)	-8.1 (11.28)

Population analysed: Change from baseline to Day 30

Primary outcome: Work Productivity and Activity Impairment Questionnaire (WPAI) Scores

Time frame: Baseline and Day 30. Mean (Standard Deviation). Unit: units on a scale

Measure	Injectafer n = 513	IV Iron Standard of Care (SOC) n = 512
Percent activity impairment due to problem	-15.2 (29.85)	-11.5 (29.43)
Percent impairment while working due to problem	-13.2 (28.75)	-8.5 (24.44)
Percent overall work impairment due to problem	-13.4 (31.66)	-8.5 (25.89)
Percent work time missed due to problem	-3.2 (23.76)	-2.5 (17.23)

Population analysed: Change from baseline to Day 30

Primary outcome: Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores

Time frame: Baseline and Day 30. Mean (Standard Deviation). Unit: units on a scale

Measure	Injectafer n = 513	IV Iron Standard of Care (SOC) n = 512
Overall Satisfaction	72.6 (25.03)	72.7 (21.07)
Effectiveness	69.3 (22.38)	66.5 (21.75)
Side Effects	63.5 (27.21)	69.2 (21.00)
Convenience	78.9 (17.31)	72.8 (20.00)

Population analysed: Change from baseline to Day 30

Primary outcome: Short Form Health Survey, 12-Item (SF-12) v2 Quality of Life Scores.

Time frame: Baseline and Day 30. Mean (Standard Deviation). Unit: units on a scale

Measure	Injectafer n = 513	IV Iron Standard of Care (SOC) n = 512
Pain	1.6 (10.03)	2.5 (10.52)
Overall Physical Health Score	3.3 (7.94)	3.1 (8.33)
Overall Mental Health Score	3.7 (10.31)	3.7 (10.39)
Physical Functioning	3.6 (10.42)	3.4 (10.45)
Role Limitation Physical	4.0 (9.53)	3.9 (9.25)
General Health	3.2 (9.86)	2.5 (9.84)
Vitality	7.7 (11.36)	7.0 (11.53)
Social Functioning	3.6 (12.19)	3.0 (11.47)

Population analysed: Change from Baseline to Day 30

Adverse events

Time frame: Day 1 to Day 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Injectafer	4 of 513 (0.8%)	28 of 513 (5.5%)	1 of 513
IV Iron Standard of Care (SOC)	1 of 512 (0.2%)	21 of 512 (4.1%)	1 of 512

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Iron Deficiency Anemia (IDA)

Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
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Recruiting
Alternate-Day vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA)
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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.

Mark Falone, MD study director

American Regent, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Injectafer and SOC in people with Iron Deficiency Anemia (IDA), run by American Regent, Inc..

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 5 inclusion and 13 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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 22 May 2025). 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?

Multidimensional Assessment of Fatigue (MAF) Scores (time frame: Baseline to Day 30). The study lists 4 primary outcomes in all. 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 NCT01950247.

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 22 May 2025.