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

NCT01131624 | Completed Phase 3 DMC

• 1 other identifier: FER-ASAP-2009-01
• Study Type: interventional
• Target: 252
• Locations: 5 countries
• Sites: 20

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.

Conditions

Anaemia

Keywords

Iron deficiency

Outcome Measures

Primary Outcomes (1)

• Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).

  3 weeks after baseline

Secondary Outcomes (3)

• 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

Study Arms (2)

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

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.

Drug: ferrous sulphate

Interventions

ferrous sulphate DRUG

200 mg iron per day in a convenient dosage schedule.

Also known as: Oral Iron

Oral Iron

Ferinject 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.

Also known as: Ferric carboxymaltose, FCM

Ferric carboxymaltose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vifor Pharma: lead
• Pierrel Research Europe GmbH: collaborator

Study Sites (20)

The Northern Hospital

Epping, Victoria, 3076, Australia

Location

Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin

Berlin, 12351, Germany

Location

Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg

Marburg, 35043, Germany

Location

Perinatalzentrum, Klinikum Innenstadt LMU

München, 80337, Germany

Location

Kvinnokliniken, Falu lasarett

Falun, SE-791, Sweden

Location

Kvinnokliniken, University Hospital

Lund, SE-221, Sweden

Location

Kvinnokliniken, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK

Stockholm, SE-141, Sweden

Location

University Hospital, Dept of obstetrics and gynecology Uppsala

Uppsala, SE-751, Sweden

Location

Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik

Basel, 4031, Switzerland

Location

Inselspital, Department of Obstetrics and Gynecology

Bern, 3010, Switzerland

Location

Humboldtstrasse

Bern, 3013, Switzerland

Location

HUG, Département de Gynécologie-Obstétrique

Geneva, 1211, Switzerland

Location

CHUV, Département de Gynécologie-Obstétrique

Lausanne, 1011, Switzerland

Location

OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia

Lugano, 6900, Switzerland

Location

Universitätsspital Zürich, Departement Frauenheilkunde

Zurich, 8091, Switzerland

Location

Cukurova University Hospital

Adana, 01330, Turkey (Türkiye)

Location

Istanbul Uni. Ist. Med. Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.

Istanbul, 34668, Turkey (Türkiye)

Location

Dr. Kutfi Kirdar Kartal Research and Education Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Interventions

ferrous sulfate; Iron; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Christian Breymann

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 27, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 29, 2015

Record last verified: 2014-12

Locations

AU (1); SE (5); CH (7); DE (3); TU (4)