Iron Deficiency AnemiaPhase 3REPAIR-IDANCT00981045
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
A Phase 3 study testing Ferric Carboxymaltose (FCM) and Iron Sucrose (Venofer) in people with Iron Deficiency Anemia and Impaired Renal Function, run by American Regent, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, Impaired Renal Function
- What is being tested?
- Ferric Carboxymaltose (FCM) and Iron Sucrose (Venofer)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,561 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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 > or = to 18 years of age.
- Chronically impaired renal function.
- Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
- Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
- If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.
Who cannot join
- Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
- No evidence of iron deficiency.
- Any non-viral infection.
- AST or ALT at screening 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 disorder 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 female subjects 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: Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.
- Conditions
- Iron Deficiency Anemia, Impaired Renal Function
- Being tested
- Ferric Carboxymaltose (FCM), Iron Sucrose (Venofer)
- Keywords
- IDA
- Medical subject headings
- Anemia, Iron-Deficiency, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Iron Sucrose (Venofer)Drug
5 doses of 200 mg for a total cumulative dose of 1000 mg
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg Receives: Drug: Ferric Carboxymaltose (FCM) |
| Iron Sucrose (Venofer) | Active comparator | 5 doses of 200 mg for a total cumulative dose of 1000 mg Receives: Drug: Iron Sucrose (Venofer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
Measured: Day 56
Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.
Measured: Day 120
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 startAug 2009
- Primary completionJul 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
- 2,561 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
- NCT00981045
- Sponsor's protocol ID
- 1VIT09030
- Acronym
- REPAIR-IDA
- Status last verified
- Jan 2018
- First submitted
- 21 Sep 2009
- 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
- Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT00981045
- Acronym / sponsor ID
- REPAIR-IDA / 1VIT09030
- Conditions
- Iron Deficiency Anemia, Impaired Renal Function
- Keywords
- IDA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,561 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jul 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 primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.
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)2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg |
| Iron Sucrose (Venofer) | Active comparator | Drug: Iron Sucrose (Venofer)5 doses of 200 mg for a total cumulative dose of 1000 mg |
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 > or = to 18 years of age.
- Chronically impaired renal function.
- Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
- Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
- If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.
Key exclusion criteria (13 listed)
- Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
- Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
- Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
- 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)2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg | Drug | Ferric Carboxymaltose (FCM) |
| Iron Sucrose (Venofer)5 doses of 200 mg for a total cumulative dose of 1000 mg | Drug | Iron Sucrose (Venofer) |
Primary outcome
Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
Time frame: Day 56
Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
Time frame: Day 120
The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.
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 Iron Sucrose (Venofer) in people with Iron Deficiency Anemia and Impaired Renal Function, 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 Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study. (time frame: Day 56). The study lists 2 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 20 Feb 2018.