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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pierrel Research Europe GmbH
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT01131624
First received: May 25, 2010
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Anaemia
Drug: ferrous sulphate
Drug: Ferinject
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: May 2010
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131624

Locations
Australia, Victoria
The Northern Hospital
Epping, Victoria, Australia, 3076
Germany
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
Sweden
Kvinnokliniken, Falu lasarett
Falun, Sweden, SE-791
Kvinnokliniken, University Hospital
Lund, Sweden, SE-221
Kvinnokliniken, Karolinska University Hospital
Stockholm, Sweden, 17176
Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK
Stockholm, Sweden, SE-141
University Hospital, Dept of obstetrics and gynecology Uppsala
Uppsala, Sweden, SE-751
Switzerland
Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik
Basel, Switzerland, 4031
Humboldtstrasse
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
Turkey
Cukurova University Hospital
Adana, Turkey, 01330
Istanbul Uni. Ist. Med. Faculty
Istanbul, Turkey, 34093
Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.
Istanbul, Turkey, 34668
Dr. Kutfi Kirdar Kartal Research and Education Hospital
Istanbul, Turkey, 34890
Sponsors and Collaborators
Vifor Inc.
Pierrel Research Europe GmbH
Investigators
Principal Investigator: Christian Breymann University of Zurich
  More Information

No publications provided

Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT01131624     History of Changes
Other Study ID Numbers: FER-ASAP-2009-01
Study First Received: May 25, 2010
Last Updated: May 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Saudi Arabia: Ministry of Health
Saudi Arabia: Ethics Committee
Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency
Switzerland: Swissmedic
Switzerland: Ethikkommission
Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Vifor Inc.:
Iron deficiency

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014