Anemia, Iron-DeficiencyPhase 2/3NCT00929409
Controlled Randomised Trial of Ferric Carboxymaltose and Oral Iron to Treat Postpartum Anemia
A Phase 2/3 study testing Ferric carboxymaltose and Ferrous sulfate tablets in people with Anemia, Iron-Deficiency and Puerperal Disorders, run by Norwegian University of Science and Technology at 3 sites in Norway.
Trial summary
200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group). The hypothesis is that intravenous iron supplementation is superior to standard peroral iron. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anemia, Iron-Deficiency, Puerperal Disorders, Depression, Postpartum
- What is being tested?
- Ferric carboxymaltose 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
- 30 participants
- Where
- 3 sitesNorway
- Study dates
- Jun 2009to Jul 2010
- Phase
- Phase 2/3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman within 48 h post partum
- Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl
- Able to read and understand the Norwegian language
- Signed informed consent
Who cannot join
- Anemia not attributable to iron deficiency
- Contraindications for any of the study drugs
- Treatment with drugs, dietary supplements or natural remedies containing iron
- Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study
- Assessed as requiring blood transfusion(s)
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Department of Obstetrics, Vestre Viken Hospital Trust
Drammen, 3004
Sykehuset Innlandet HF
Lillehammer, N 2609
St Olavs Hospital
Trondheim, N 7006
About this study
Official title: A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia
200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).
The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.
Read the detailed description
The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway.
The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.
The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).
Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.
Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.
- Being tested
- Ferric carboxymaltose, Ferrous sulfate tablets
- Keywords
- Postpartum anemia, iron-deficiency
- Medical subject headings
- Anemia, Iron-Deficiency, Puerperal Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject
Intravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula
Ferrous sulfate tabletsDrug
Also called Duroferon
Standard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily
| Study group | Role | What they receive |
|---|---|---|
| Peroral iron - ferrous sulfate tablets | Active comparator | Peroral iron given as one tablet of ferrous sulfate 100 mg two times daily Receives: Drug: Ferrous sulfate tablets |
| Ferric carboxymaltose | Active comparator | Intravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given. Receives: Drug: Ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin concentration
Measured: 6 weeks
Secondary outcomes (4)
Ferritin
Measured: 6 weeks
Fatigue
Fatigue scale
Measured: 6 weeks
Quality of life
SF-36
Measured: 6 weeks
Post partum depression
Edinburgh Post Partum Depression Scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Stopped prematurely because too few patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Innlandet HF, Sykehuset Buskerud HF
- Responsible party
- Sponsor
- Investigators
- Bjorn Backe, MD PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929409
- Sponsor's protocol ID
- 4.2009.373
- Other IDs
- 21830, 09/03045-4, 2008-008526-79, 2008
- Status last verified
- Feb 2012
- First submitted
- 26 Jun 2009
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week Randomised, Open Comparative, Multi-centre Study of Intravenous Ferric Carboxymaltose (Ferinject) and Oral Iron (Duroferon) for Treatment of Post Partum Anemia
- ClinicalTrials.gov ID
- NCT00929409
- Acronym / sponsor ID
- 4.2009.373
- Keywords
- Postpartum anemia, iron-deficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped prematurely because too few patients were recruited.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Sykehuset Innlandet HF, Sykehuset Buskerud HF
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jun 2009 (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.
200 patients with post partum anemia will be randomised to receive either intravenous iron (intervention group) or peroral iron (control group).
The hypothesis is that intravenous iron supplementation is superior to standard peroral iron.
Detailed description
The study is a multi center phase 3 trial, comprising 3 medium sized obstetrical units in Norway.
The amount of iron given to the intervention group is calculated according to the modified Ganzoni formula. The control group is given the standard regime of 200 mg ferro sulphate daily. In both groups, treatment start at inclusion, within 48 h of delivery.
The sample size was based on power calculations: About 200 participants are required to detect a difference of 0.5 g/dl between the groups (with 80 % power).
Randomization is performed by use of opaque envelopes. An electronic CRF is applied. Laboratory analysis are provided by a recognized Swedish biochemical laboratory.
Apart from hemoglobin and the common iron parameters, the serum concentration of soluble ferritin receptors will be analyzed, as well as hepcidin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peroral iron - ferrous sulfate tablets | Active comparator | Drug: Ferrous sulfate tabletsPeroral iron given as one tablet of ferrous sulfate 100 mg two times daily |
| Ferric carboxymaltose | Active comparator | Drug: Ferric carboxymaltoseIntravenous infusion of Ferric Carboxymaltose (Ferinject), the given dose is adapted according to the individual patient's requirement. No other form of iron supplementation is given. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman within 48 h post partum
- Hemoglobin level equal or higher than 6.5 g/dl and equal or lower than 8.5 g/dl
- Able to read and understand the Norwegian language
- Signed informed consent
Key exclusion criteria (5 listed)
- Anemia not attributable to iron deficiency
- Contraindications for any of the study drugs
- Treatment with drugs, dietary supplements or natural remedies containing iron
- Clinically significant condition which in the opinion of the investigator should disqualify the patient from the study
- Assessed as requiring blood transfusion(s)
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 carboxymaltoseAlso: FerinjectIntravenous infusion of Ferric carboxymaltose in a dose calculated to meet the individual patient's requirements following the Ganzoni formula | Drug | Ferric carboxymaltose |
| Ferrous sulfate tabletsAlso: DuroferonStandard tablets containing 100 mg ferrous sulfate, 1 tablet two times daily | Drug | Peroral iron - ferrous sulfate tablets |
Primary outcome
Haemoglobin concentration
Time frame: 6 weeks
4 secondary outcomes
Ferritin
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Quality of life
Time frame: 6 weeks
Post partum depression
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Stopped prematurely because too few patients were recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
Bjorn Backe, MD PhD principal investigator
Norwegian University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ferric carboxymaltose and Ferrous sulfate tablets in people with Anemia, Iron-Deficiency and Puerperal Disorders, run by Norwegian University of Science and Technology at 3 sites in Norway.
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: stopped early, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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 combined 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.
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?
The study was stopped early (reason given: Stopped prematurely because too few patients were recruited.). Results are not available in the source record.
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?
Haemoglobin concentration (time frame: 6 weeks). 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 17 Feb 2012.