Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women

NCT ID: NCT01131624

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-04-30

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).

Conditions

Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Ferinject

Intervention Type: DRUG

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.

Oral Iron

Oral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule.

Group Type: ACTIVE_COMPARATOR

ferrous sulphate

Intervention Type: DRUG

200 mg iron per day in a convenient dosage schedule.

Interventions

ferrous sulphate

200 mg iron per day in a convenient dosage schedule.

Intervention Type: DRUG

Ferinject

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.

Intervention Type: DRUG

Other Intervention Names

Oral Iron; Ferric carboxymaltose; FCM

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierrel Research Europe GmbH

INDUSTRY

Sponsor Role: collaborator

Vifor Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Breymann

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

The Northern Hospital

Epping, Victoria, Australia

Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin

Berlin, , Germany

Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg

Marburg, , Germany

Perinatalzentrum, Klinikum Innenstadt LMU

München, , Germany

Kvinnokliniken, Falu lasarett

Falun, , Sweden

Kvinnokliniken, University Hospital

Lund, , Sweden

Kvinnokliniken, Karolinska University Hospital

Stockholm, , Sweden

Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK

Stockholm, , Sweden

University Hospital, Dept of obstetrics and gynecology Uppsala

Uppsala, , Sweden

Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik

Basel, , Switzerland

Inselspital, Department of Obstetrics and Gynecology

Bern, , Switzerland

Humboldtstrasse

Bern, , Switzerland

HUG, Département de Gynécologie-Obstétrique

Geneva, , Switzerland

CHUV, Département de Gynécologie-Obstétrique

Lausanne, , Switzerland

OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia

Lugano, , Switzerland

Universitätsspital Zürich, Departement Frauenheilkunde

Zurich, , Switzerland

Cukurova University Hospital

Adana, , Turkey (Türkiye)

Istanbul Uni. Ist. Med. Faculty

Istanbul, , Turkey (Türkiye)

Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.

Istanbul, , Turkey (Türkiye)

Dr. Kutfi Kirdar Kartal Research and Education Hospital

Istanbul, , Turkey (Türkiye)

Countries

Australia; Germany; Sweden; Switzerland; Turkey (Türkiye)

Other Identifiers

FER-ASAP-2009-01

Identifier Type: -

Identifier Source: org_study_id