Clinical trial NCT01131624: Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anaemia
Keywords: Iron deficiency
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
Collaborators: name: Pierrel Research Europe GmbH
First posted: 2010-05-27
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
timeFrame: 3 weeks after baseline
Secondary outcomes:
measure: Change in Hb from baseline at Week 6
timeFrame: 6 weeks after baseline
measure: Change in Hb from baseline at Week 9
timeFrame: 9 weeks after baseline
measure: Change in Hb from baseline at Week 12
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin
city: Marburg
country: Germany
facility: Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg
city: München
country: Germany
facility: Perinatalzentrum, Klinikum Innenstadt LMU
city: Falun
country: Sweden
facility: Kvinnokliniken, Falu lasarett
city: Lund
country: Sweden
facility: Kvinnokliniken, University Hospital
city: Stockholm
country: Sweden
facility: Kvinnokliniken, Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK
city: Uppsala
country: Sweden
facility: University Hospital, Dept of obstetrics and gynecology Uppsala
city: Basel
country: Switzerland
facility: Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik
city: Bern
country: Switzerland
facility: Inselspital, Department of Obstetrics and Gynecology
city: Bern
country: Switzerland
facility: Humboldtstrasse
city: Genève
country: Switzerland
facility: HUG, Département de Gynécologie-Obstétrique
city: Lausanne
country: Switzerland
facility: CHUV, Département de Gynécologie-Obstétrique
city: Lugano
country: Switzerland
facility: OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich, Departement Frauenheilkunde
city: Adana
country: Turkey
facility: Cukurova University Hospital
city: Istanbul
country: Turkey
facility: Istanbul Uni. Ist. Med. Faculty
city: Istanbul
country: Turkey
facility: Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.
city: Istanbul
country: Turkey
facility: Dr. Kutfi Kirdar Kartal Research and Education Hospital
Study officials:
affiliation: University of Zurich
name: Christian Breymann
role: PRINCIPAL_INVESTIGATOR
References: