Iron Deficiency AnemiaPhase 2NCT01290315
Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
A Phase 2 study testing Ferric Carboxymaltose (FCM) and Iron Sucrose / Iron Dextran in people with Iron Deficiency Anemia, run by American Regent, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferric Carboxymaltose (FCM) and Iron Sucrose / Iron Dextran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2013
- Phase
- Phase 2
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects 18-50 years of age and able to give informed consent.
- If post-partum, at least 10 days post delivery at Day 0.
- Screening Visit local laboratory Hgb < or = to 10 g/dL or < or = to 12 g/dL with symptoms (dizziness and/or fatigue).
- Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when TSAT is < or = to 30%.
- Documented unsatisfactory response or intolerance to oral iron.
Who cannot join
- Previous participation in a ferric carboxymaltose (FCM) clinical trial.
- Known hypersensitivity reaction to any component of ferric carboxymaltose, Venofer, or Dexferrum.
- History of drug allergy or any history of rheumatoid arthritis or other autoimmune diseases.
- Current anemia not attributed to iron deficiency.
- During the 10 day period prior to screening has been treated with antibiotics.
- During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents.
Show all 26Show fewer
- Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary.
- During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia.
- Current (acute or chronic) infection other than viral upper respiratory tract infection.
- AST or ALT at screening greater than 1.5 times the upper limit of normal.
- Known positive hepatitis B with evidence of active hepatitis.
- Known positive HIV-1/HIV-2 antibodies (anti-HIV).
- Patient has an active diagnosis of asthma and is currently using an anti- asthmatic therapy.
- Received an investigational drug within 30 days of screening.
- Alcohol or drug abuse within the past 6 months.
- Hemochromatosis or other iron storage disorders.
- Systolic blood pressure > or = to 180 or < 80 mmHg or diastolic blood pressure > or = to 100 or < 40 mmHg at screening or Day 0.
- Chronic kidney disease.
- Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
- Pre-term delivery < 32 weeks.
- Emergent C-section delivery.
- Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure.
- Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
- Night shift workers.
- Breastfeeding planned on or after Day 0.
- Pregnant or sexually-active female subjects who are of childbearing potential and who don't 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 Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.
Read the detailed description
This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all inclusion and no exclusion criteria, and had given informed consent were randomized. The duration of the study for each subject was a maximum of 6 weeks.
Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV iron dextran (Group B).
Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500 mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was preceded by a 25 mg test dose 1 hour prior to infusion.
All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours post-infusion, Day 7 (drawn at the same time of day [within 4 hours] as the 24-hour visit), and Day 30 (drawn at the same time of day [within 4 hours] as the the 24-hour visit). On Days 7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event reporting, concomitant medication review, physical examination including vital signs, and laboratory assessments. Any subject who withdrew from the study received a follow-up phone call 30 days after they received study drug.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferric Carboxymaltose (FCM), Iron Sucrose / Iron Dextran
- 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
Also called Injectafer
One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
Iron Sucrose / Iron DextranDrug
Also called Venofer, Dexferrum
One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | Intravenous iron Receives: Drug: Ferric Carboxymaltose (FCM) |
| Iron Sucrose / Iron Dextran | Active comparator | Intravenous iron Receives: Drug: Iron Sucrose / Iron Dextran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Measured: Change from Baseline to Day 30
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Measured: Change from baseline to 2 hours post end IV infusion
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Measured: Change from baseline to 24 hours post end IV infusion
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Measured: Change from baseline to Day 7 post end IV infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionMar 2013
- Study completionAug 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda M Mundy, MD, PhD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290315
- Sponsor's protocol ID
- 1VIT08022
- Status last verified
- Feb 2018
- First submitted
- 10 Nov 2010
- Last updated
- 8 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
- ClinicalTrials.gov ID
- NCT01290315
- Acronym / sponsor ID
- 1VIT08022
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 8 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.
Detailed description
This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all inclusion and no exclusion criteria, and had given informed consent were randomized. The duration of the study for each subject was a maximum of 6 weeks.
Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV iron dextran (Group B).
Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500 mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was preceded by a 25 mg test dose 1 hour prior to infusion.
All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours post-infusion, Day 7 (drawn at the same time of day [within 4 hours] as the 24-hour visit), and Day 30 (drawn at the same time of day [within 4 hours] as the the 24-hour visit). On Days 7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event reporting, concomitant medication review, physical examination including vital signs, and laboratory assessments. Any subject who withdrew from the study received a follow-up phone call 30 days after they received study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | Drug: Ferric Carboxymaltose (FCM)Intravenous iron |
| Iron Sucrose / Iron Dextran | Active comparator | Drug: Iron Sucrose / Iron DextranIntravenous iron |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female subjects 18-50 years of age and able to give informed consent.
- If post-partum, at least 10 days post delivery at Day 0.
- Screening Visit local laboratory Hgb < or = to 10 g/dL or < or = to 12 g/dL with symptoms (dizziness and/or fatigue).
- Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when TSAT is < or = to 30%.
- Documented unsatisfactory response or intolerance to oral iron.
Key exclusion criteria (26 listed)
- Previous participation in a ferric carboxymaltose (FCM) clinical trial.
- Known hypersensitivity reaction to any component of ferric carboxymaltose, Venofer, or Dexferrum.
- History of drug allergy or any history of rheumatoid arthritis or other autoimmune diseases.
- Current anemia not attributed to iron deficiency.
- During the 10 day period prior to screening has been treated with antibiotics.
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)Also: InjectaferOne 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II) | Drug | Ferric Carboxymaltose (FCM) |
| Iron Sucrose / Iron DextranAlso: Venofer, DexferrumOne 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II) | Drug | Iron Sucrose / Iron Dextran |
Primary outcome
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Time frame: Change from Baseline to Day 30
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Time frame: Change from baseline to 2 hours post end IV infusion
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Time frame: Change from baseline to 24 hours post end IV infusion
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Time frame: Change from baseline to Day 7 post end IV infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Linda M Mundy, MD, PhD study director
American Regent, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferric Carboxymaltose (FCM) and Iron Sucrose / Iron Dextran 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 26 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 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Feb 2018). 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?
Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane) (time frame: Change from 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?
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 8 Feb 2018.