AnaemiaPhase 3ASAPNCT01131624
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
A Phase 3 study testing ferrous sulphate and Ferinject in people with Anaemia, run by Vifor Pharma at 20 sites in 5 countries.
Trial summary
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anaemia
- What is being tested?
- ferrous sulphate and Ferinject
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 20 sitesin 5 countries
- Study dates
- May 2010to Apr 2015
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women aged ≥18, gestational week ≥20, ≤33 at baseline visit with normal antenatal screening test results.
- Iron deficiency anaemia defined as Hb concentration ≥8 g/dl and ≤10.4 g/dL and serum ferritin ≤20 mcg/L at screening.
- Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study.
Who cannot join
- Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study.
- Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.
- Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening.
- Pre-eclampsia.
- Multiple pregnancy.
- Evidence on any significant abnormalities on anomaly ultrasound.
Show all 20Show fewer
- Haemochromatosis or other iron storage disorders.
- Folate deficiency (S-folate <4.5 nmol/L) at screening.
- Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening.
- Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study.
- Known chronic renal failure (defined as creatinine clearance <30 mL/min calculated by Cockcroft-Gault or modification of diet in renal disease formula).
- Severe cardiovascular diseases.
- Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.
- Inability to fully comprehend and/or perform study procedures in the Investigator's opinion
- History of endocrine disorders
- Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia
- Recent significant bleeding/surgery (within the 3 months prior to screening).
- Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening.
- Participation in any other interventional study since estimated conception and throughout study participation.
- Known hypersensitivity to FCM or other IV iron preparations.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Switzerland7 sites
Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik
Basel, 4031
Inselspital, Department of Obstetrics and Gynecology
Bern, 3010
Humboldtstrasse
Bern, 3013
HUG, Département de Gynécologie-Obstétrique
Geneva, 1211
CHUV, Département de Gynécologie-Obstétrique
Lausanne, 1011
OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia
Lugano, 6900
Universitätsspital Zürich, Departement Frauenheilkunde
Zurich, 8091
Sweden5 sites
Kvinnokliniken, Falu lasarett
Falun, SE-791
Kvinnokliniken, University Hospital
Lund, SE-221
Kvinnokliniken, Karolinska University Hospital
Stockholm, 17176
Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK
Stockholm, SE-141
University Hospital, Dept of obstetrics and gynecology Uppsala
Uppsala, SE-751
Turkey (Türkiye)4 sites
Cukurova University Hospital
Adana, 01330
Istanbul Uni. Ist. Med. Faculty
Istanbul, 34093
Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.
Istanbul, 34668
Dr. Kutfi Kirdar Kartal Research and Education Hospital
Istanbul, 34890
Germany3 sites
Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin
Berlin, 12351
Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg
Marburg, 35043
Perinatalzentrum, Klinikum Innenstadt LMU
München, 80337
About this study
Official title: An Open-label, Multicentre, Randomised, 2-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Pregnant Women
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.
Read the detailed description
This is an open-label, multicentre, randomised, 2-arm study to assess the efficacy and safety of FCM compared to oral iron in pregnant women with IDA.
During the screening period (Days -10 to 0 before randomisation), subjects will be selected based on eligibility criteria. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will undergo baseline assessments at baseline (Day 0) prior to the first dose of study medication.
Subjects will be randomised to receive either intravenous (IV) iron (FCM, 1,000-1,500 mg) or oral iron (ferrous sulphate, 100 mg iron twice a day; total dose 200 mg/day).
The treatment period will begin with the infusion of FCM or the intake of oral iron on Day 0.
All subjects will return for assessment of efficacy and safety at Weeks 3, 6, 9, 12 and at delivery (or whichever comes first).
- Conditions
- Anaemia
- Being tested
- ferrous sulphate, Ferinject
- Keywords
- Iron deficiency
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous sulphateDrug
Also called Oral Iron
200 mg iron per day in a convenient dosage schedule.
FerinjectDrug
Also called Ferric carboxymaltose, FCM
1000-1500mg diluted only in sterile 0.9% sodium chloride, The maximum single dose of FCM that can be administered by intravenous infusion is 20 mL (1,000 mg iron) but should not exceed 15 mg of iron per kg of body weight. This means that for subjects with a bw below 66 kg a maximal dose of 500 mg iron per infusion is allowed.
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Active comparator | Subjects with bw ≥66 kg will receive an infusion of 1,000 mg iron as FCM and after 1 week a further 500 mg iron as FCM, depending on Hb at screening.
subjects with bw <66 kg, 2-3 infusions of 500 mg iron as FCM will be administered within 2 weeks from baseline, depending on Hb at screening Receives: Drug: Ferinject |
| Oral Iron | Active comparator | Oral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule. Receives: Drug: ferrous sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
Measured: 3 weeks after baseline
Secondary outcomes (3)
Change in Hb from baseline at Week 6
Measured: 6 weeks after baseline
Change in Hb from baseline at Week 9
Measured: 9 weeks after baseline
Change in Hb from baseline at Week 12
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pierrel Research Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Christian Breymann, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131624
- Sponsor's protocol ID
- FER-ASAP-2009-01
- Acronym
- ASAP
- Status last verified
- Dec 2014
- First submitted
- 25 May 2010
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicentre, Randomised, 2-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Pregnant Women
- ClinicalTrials.gov ID
- NCT01131624
- Acronym / sponsor ID
- ASAP / FER-ASAP-2009-01
- Conditions
- Anaemia
- Keywords
- Iron deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Pierrel Research Europe GmbH
- Study start
- May 2010
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 May 2010 (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 purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.
Detailed description
This is an open-label, multicentre, randomised, 2-arm study to assess the efficacy and safety of FCM compared to oral iron in pregnant women with IDA.
During the screening period (Days -10 to 0 before randomisation), subjects will be selected based on eligibility criteria. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will undergo baseline assessments at baseline (Day 0) prior to the first dose of study medication.
Subjects will be randomised to receive either intravenous (IV) iron (FCM, 1,000-1,500 mg) or oral iron (ferrous sulphate, 100 mg iron twice a day; total dose 200 mg/day).
The treatment period will begin with the infusion of FCM or the intake of oral iron on Day 0.
All subjects will return for assessment of efficacy and safety at Weeks 3, 6, 9, 12 and at delivery (or whichever comes first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Active comparator | Drug: FerinjectSubjects with bw ≥66 kg will receive an infusion of 1,000 mg iron as FCM and after 1 week a further 500 mg iron as FCM, depending on Hb at screening. subjects with bw <66 kg, 2-3 infusions of 500 mg iron as FCM will be administered within 2 weeks from baseline, depending on Hb at screening |
| Oral Iron | Active comparator | Drug: ferrous sulphateOral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women aged ≥18, gestational week ≥20, ≤33 at baseline visit with normal antenatal screening test results.
- Iron deficiency anaemia defined as Hb concentration ≥8 g/dl and ≤10.4 g/dL and serum ferritin ≤20 mcg/L at screening.
- Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study.
Key exclusion criteria (20 listed)
- Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study.
- Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.
- Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening.
- Pre-eclampsia.
- Multiple pregnancy.
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 |
|---|---|---|
| ferrous sulphateAlso: Oral Iron200 mg iron per day in a convenient dosage schedule. | Drug | Oral Iron |
| FerinjectAlso: Ferric carboxymaltose, FCM1000-1500mg diluted only in sterile 0.9% sodium chloride, The maximum single dose of FCM that can be administered by intravenous infusion is 20 mL (1,000 mg iron) but should not exceed 15 mg of iron per kg of body weight. This means that for subjects with a bw below 66 kg a maximal dose of 500 mg iron per infusion is allowed. | Drug | Ferric carboxymaltose |
Primary outcome
Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
Time frame: 3 weeks after baseline
3 secondary outcomes
Change in Hb from baseline at Week 6
Time frame: 6 weeks after baseline
Change in Hb from baseline at Week 9
Time frame: 9 weeks after baseline
Change in Hb from baseline at Week 12
Time frame: 12 weeks after baseline
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 29 May 2015.
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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.
Christian Breymann principal investigator
University of Zurich
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ferrous sulphate and Ferinject in people with Anaemia, run by Vifor Pharma at 20 sites in 5 countries.
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 3 inclusion and 20 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Switzerland, Sweden, Turkey (Türkiye), Germany, Australia. 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?
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?
Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority). (time frame: 3 weeks after baseline). 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 29 May 2015.