Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
- Registration Number
- NCT01131624
- Lead Sponsor
- Vifor Pharma
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 252
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ferric carboxymaltose Ferinject 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 Oral Iron ferrous sulphate Oral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule.
- Primary Outcome Measures
Name Time Method Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority). 3 weeks after baseline
- Secondary Outcome Measures
Name Time Method Change in Hb from baseline at Week 6 6 weeks after baseline Change in Hb from baseline at Week 9 9 weeks after baseline Change in Hb from baseline at Week 12 12 weeks after baseline
Trial Locations
- Locations (20)
Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik
🇨🇭Basel, Switzerland
Humboldtstrasse
🇨🇭Bern, Switzerland
OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia
🇨🇭Lugano, Switzerland
HUG, Département de Gynécologie-Obstétrique
🇨🇭Genève, Switzerland
Universitätsspital Zürich, Departement Frauenheilkunde
🇨🇭Zürich, Switzerland
Cukurova University Hospital
🇹🇷Adana, Turkey
CHUV, Département de Gynécologie-Obstétrique
🇨🇭Lausanne, Switzerland
Dr. Kutfi Kirdar Kartal Research and Education Hospital
🇹🇷Istanbul, Turkey
Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin
🇩🇪Berlin, Germany
Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg
🇩🇪Marburg, Germany
Perinatalzentrum, Klinikum Innenstadt LMU
🇩🇪München, Germany
Kvinnokliniken, University Hospital
🇸🇪Lund, Sweden
Kvinnokliniken, Karolinska University Hospital
🇸🇪Stockholm, Sweden
University Hospital, Dept of obstetrics and gynecology Uppsala
🇸🇪Uppsala, Sweden
The Northern Hospital
🇦🇺Epping, Victoria, Australia
Inselspital, Department of Obstetrics and Gynecology
🇨🇭Bern, Switzerland
Istanbul Uni. Ist. Med. Faculty
🇹🇷Istanbul, Turkey
Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.
🇹🇷Istanbul, Turkey
Kvinnokliniken, Falu lasarett
🇸🇪Falun, Sweden
Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK
🇸🇪Stockholm, Sweden