AnemiaPhase 3NCT00704353
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
A Phase 3 study testing Ferric Carboxymaltose and Standard Medical Care (SMC) in people with Anemia, run by American Regent, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Ferric Carboxymaltose and Standard Medical Care (SMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 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
- Subjects ≥18 years of age and able to give informed consent
- Iron deficiency is the primary etiology of anemia
- Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
- Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Who cannot join
- Previous participation in a FCM trial
- Known hypersensitivity reaction to FCM
- Requires dialysis for treatment of chronic kidney disease
- Current anemia not attributed to iron deficiency
- Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
- Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period
Show all 9Show fewer
- AST of ALT greater than 1.5 times the upper limit of normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually-active females who are not able to use an effective form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals
Norristown, Pennsylvania, 19403
About this study
Official title: A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
- Conditions
- Anemia
- Being tested
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CarboxymaltoseDrug
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Standard Medical Care (SMC)Drug
Also called Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum
Per product label
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. Receives: Drug: Ferric Carboxymaltose |
| Standard Medical Care | Active comparator | Per product label Receives: Drug: Standard Medical Care (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Measured: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionMar 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 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
- 735 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
- NCT00704353
- Sponsor's protocol ID
- 1VIT08021
- Status last verified
- Jan 2018
- First submitted
- 20 Jun 2008
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent
- ClinicalTrials.gov ID
- NCT00704353
- Acronym / sponsor ID
- 1VIT08021
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
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 Carboxymaltose15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. |
| Standard Medical Care | Active comparator | Drug: Standard Medical Care (SMC)Per product label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥18 years of age and able to give informed consent
- Iron deficiency is the primary etiology of anemia
- Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
- Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Key exclusion criteria (9 listed)
- Previous participation in a FCM trial
- Known hypersensitivity reaction to FCM
- Requires dialysis for treatment of chronic kidney disease
- Current anemia not attributed to iron deficiency
- Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
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 Carboxymaltose15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. | Drug | Ferric Carboxymaltose (FCM) |
| Standard Medical Care (SMC)Also: Ferrous Sulfate, Venofer, Ferrlecit, Infed, DexferrumPer product label | Drug | Standard Medical Care |
Primary outcome
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Time frame: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
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 and Standard Medical Care (SMC) in people with 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 4 inclusion and 9 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 25 Nov 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?
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) (time frame: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)). 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.