Iron Deficiency AnemiaPhase 3NCT00982007
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
A Phase 3 study testing Ferric Carboxymaltose (FCM) and Ferrous Sulfate Tablets in people with Iron Deficiency Anemia, run by American Regent, Inc. at 1 site in United States.
Trial summary
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferric Carboxymaltose (FCM) and Ferrous Sulfate Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 997 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2011
- Phase
- Phase 3
- 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 ≥ to 18 years of age and able to give informed consent.
- Diagnosis of Iron Deficiency Anemia (IDA).
- Hemoglobin (Hgb) ≤ to 11 g/dL.
- Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
- Must demonstrate an unsatisfactory response or intolerance to oral iron.
Who cannot join
- Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease.
- No evidence of iron deficiency.
- Any non-viral infection.
- AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
Show all 13Show fewer
- 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 ECOG Performance Status greater than 1.
- 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.
- Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, 19403
About this study
Official title: A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferric Carboxymaltose (FCM), Ferrous Sulfate Tablets, IV Iron (standard of care)
- Keywords
- IDA
- 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.
Ferric Carboxymaltose (FCM)Drug
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Ferrous Sulfate TabletsDrug
325 mg Ferrous Sulfate tablets taken orally three times a day
IV Iron (standard of care)Drug
IV standard of care (other IV iron) per the Investigator's discretion
Ferric Carboxymaltose (FCM)Drug
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | Experimental | Intravenous (IV) iron Receives: Drug: Ferric Carboxymaltose (FCM) |
| Cohort 1 (Group B) - Ferrous Sulfate | Active comparator | Oral iron - Ferrous Sulfate tablets Receives: Drug: Ferrous Sulfate Tablets |
| Cohort 2 (Group D) - IV Iron (standard of care) | Active comparator | Other IV iron Receives: Drug: IV Iron (standard of care) |
| Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | Experimental | Intravenous (IV) iron Receives: Drug: Ferric Carboxymaltose (FCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionAug 2011
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 AnemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 997 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982007
- Sponsor's protocol ID
- 1VIT09031
- Status last verified
- Jan 2018
- First submitted
- 21 Sep 2009
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
- ClinicalTrials.gov ID
- NCT00982007
- Acronym / sponsor ID
- 1VIT09031
- Conditions
- Iron Deficiency Anemia
- Keywords
- IDA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 997 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 18 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) | Experimental | Drug: Ferric Carboxymaltose (FCM)Intravenous (IV) iron |
| Cohort 1 (Group B) - Ferrous Sulfate | Active comparator | Drug: Ferrous Sulfate TabletsOral iron - Ferrous Sulfate tablets |
| Cohort 2 (Group D) - IV Iron (standard of care) | Active comparator | Drug: IV Iron (standard of care)Other IV iron |
| Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) | Experimental | Drug: Ferric Carboxymaltose (FCM)Intravenous (IV) iron |
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 ≥ to 18 years of age and able to give informed consent.
- Diagnosis of Iron Deficiency Anemia (IDA).
- Hemoglobin (Hgb) ≤ to 11 g/dL.
- Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
- Must demonstrate an unsatisfactory response or intolerance to oral iron.
Key exclusion criteria (13 listed)
- Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease.
- No evidence of iron deficiency.
- Any non-viral infection.
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 |
|---|---|---|
| Ferric Carboxymaltose (FCM)A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. | Drug | Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) |
| Ferrous Sulfate Tablets325 mg Ferrous Sulfate tablets taken orally three times a day | Drug | Cohort 1 (Group B) - Ferrous Sulfate |
| IV Iron (standard of care)IV standard of care (other IV iron) per the Investigator's discretion | Drug | Cohort 2 (Group D) - IV Iron (standard of care) |
| Ferric Carboxymaltose (FCM)A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. | Drug | Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) |
Primary outcome
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
Time frame: Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Carboxymaltose (FCM) and Ferrous Sulfate Tablets in people with Iron Deficiency Anemia, run by American Regent, Inc. at 1 site in United States.
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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Oct 2013). 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?
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate. (time frame: Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2018.