Iron Deficiency Anemia (IDA)NCT01984554
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
An observational study of Iron Deficiency Anemia (IDA), run by American Regent, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia (IDA)
- Type of treatment
- Injection or infusion
- How many people
- 551 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects presenting for IDA treatment
Who may be able to join
- Must present for the first dose of a current cycle of IV treatment for IDA
- Must be over 18 years of age
- Must be willing and able to provide informed consent, including permission to obtain information from their medical records.
- Must be able to read and understand English.
Who cannot join
- Subjects not diagnosed with IDA.
- Subjects requiring more than one treatment cycle within 30 days.
- Subjects receiving maintenance IV iron therapy.
- Subjects treated with IV iron within the 30-day period prior to study enrollment.
- Subjects who received investigational medication in the six months prior to the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, 19403
About this study
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.
Read the detailed description
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.
- Conditions
- Iron Deficiency Anemia (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.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician. | |
| Iron Sucrose | Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician | |
| Iron Dextran | Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician | |
| Ferumoxytol | Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).
Measured: 30 day observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 551 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
- NCT01984554
- Sponsor's protocol ID
- 1VIT13033
- Status last verified
- Jan 2018
- First submitted
- 8 Nov 2013
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT01984554
- Acronym / sponsor ID
- 1VIT13033
- Conditions
- Iron Deficiency Anemia (IDA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
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 compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.
Detailed description
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose (FCM) | – | –Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician. |
| Iron Sucrose | – | –Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician |
| Iron Dextran | – | –Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician |
| Ferumoxytol | – | –Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting for IDA treatment
Key inclusion criteria (4 listed)
- Must present for the first dose of a current cycle of IV treatment for IDA
- Must be over 18 years of age
- Must be willing and able to provide informed consent, including permission to obtain information from their medical records.
- Must be able to read and understand English.
Key exclusion criteria (5 listed)
- Subjects not diagnosed with IDA.
- Subjects requiring more than one treatment cycle within 30 days.
- Subjects receiving maintenance IV iron therapy.
- Subjects treated with IV iron within the 30-day period prior to study enrollment.
- Subjects who received investigational medication in the six months prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).
Time frame: 30 day observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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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?
An observational study of Iron Deficiency Anemia (IDA), 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 5 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 24 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form). (time frame: 30 day observation period). 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 24 Jan 2018.