Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women (ASAP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority). [ Time Frame: 3 weeks after baseline ] [ Designated as safety issue: No ]
- Change in Hb from baseline at Week 6 [ Time Frame: 6 weeks after baseline ] [ Designated as safety issue: No ]
- Change in Hb from baseline at Week 9 [ Time Frame: 9 weeks after baseline ] [ Designated as safety issue: No ]
- Change in Hb from baseline at Week 12 [ Time Frame: 12 weeks after baseline ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||May 2015|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Ferric carboxymaltose
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
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.
Other Name: Ferinject
Active Comparator: Oral Iron
Oral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule.
Drug: ferrous sulphate
200 mg iron per day in a convenient dosage schedule.
Other Name: Oral Iron
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131624
|The Northern Hospital|
|Epping, Victoria, Australia, 3076|
|Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin|
|Berlin, Germany, 12351|
|Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg|
|Marburg, Germany, 35043|
|Perinatalzentrum, Klinikum Innenstadt LMU|
|München, Germany, 80337|
|Kvinnokliniken, Falu lasarett|
|Falun, Sweden, SE-791|
|Kvinnokliniken, University Hospital|
|Lund, Sweden, SE-221|
|Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK|
|Stockholm, Sweden, SE-141|
|Kvinnokliniken, Karolinska University Hospital|
|Stockholm, Sweden, 17176|
|University Hospital, Dept of obstetrics and gynecology Uppsala|
|Uppsala, Sweden, SE-751|
|Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik|
|Basel, Switzerland, 4031|
|Bern, Switzerland, 3013|
|Inselspital, Department of Obstetrics and Gynecology|
|Bern, Switzerland, 3010|
|HUG, Département de Gynécologie-Obstétrique|
|Genève, Switzerland, 1211|
|CHUV, Département de Gynécologie-Obstétrique|
|Lausanne, Switzerland, 1011|
|OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia|
|Lugano, Switzerland, 6900|
|Universitätsspital Zürich, Departement Frauenheilkunde|
|Zürich, Switzerland, 8091|
|Cukurova University Hospital|
|Adana, Turkey, 01330|
|Dr. Kutfi Kirdar Kartal Research and Education Hospital|
|Istanbul, Turkey, 34890|
|Istanbul Uni. Ist. Med. Faculty|
|Istanbul, Turkey, 34093|
|Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.|
|Istanbul, Turkey, 34668|
|Principal Investigator:||Christian Breymann||University of Zurich|