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

Anaemia Clinical Trial

— ASAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131624
• Other study ID #: FER-ASAP-2009-01
• Status: Completed
• Phase: Phase 3
• First received: May 25, 2010
• Last updated: May 27, 2015
• Start date: May 2010
• Est. completion date: April 2015

Study information

• Verified date: December 2014
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionSweden: Regional Ethical Review BoardSweden: Medical Products AgencySwitzerland: SwissmedicSwitzerland: EthikkommissionTurkey: Ethics CommitteeTurkey: Ministry of HealthRussia: Ministry of Health of the Russian FederationRussia: Ethics CommitteeSingapore: Ministry of HealthSingapore: Institutional Review BoardAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteePhilippines : Food and Drug AdministrationPhilippines: Ethics CommitteeSouth Korea: Korea Food and Drug Administration (KFDA)South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: April 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• ferrous sulphate
200 mg iron per day in a convenient dosage schedule.
• 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.

Locations

Country	Name	City	State
Australia	The Northern Hospital	Epping	Victoria
Germany	Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin	Berlin
Germany	Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg	Marburg
Germany	Perinatalzentrum, Klinikum Innenstadt LMU	München
Sweden	Kvinnokliniken, Falu lasarett	Falun
Sweden	Kvinnokliniken, University Hospital	Lund
Sweden	Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK	Stockholm
Sweden	Kvinnokliniken, Karolinska University Hospital	Stockholm
Sweden	University Hospital, Dept of obstetrics and gynecology Uppsala	Uppsala
Switzerland	Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik	Basel
Switzerland	Humboldtstrasse	Bern
Switzerland	Inselspital, Department of Obstetrics and Gynecology	Bern
Switzerland	HUG, Département de Gynécologie-Obstétrique	Genève
Switzerland	CHUV, Département de Gynécologie-Obstétrique	Lausanne
Switzerland	OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia	Lugano
Switzerland	Universitätsspital Zürich, Departement Frauenheilkunde	Zürich
Turkey	Cukurova University Hospital	Adana
Turkey	Dr. Kutfi Kirdar Kartal Research and Education Hospital	Istanbul
Turkey	Istanbul Uni. Ist. Med. Faculty	Istanbul
Turkey	Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Inc.	Pierrel Research Europe GmbH

Countries where clinical trial is conducted

Australia,  Germany,  Sweden,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).		3 weeks after baseline	No
Secondary	Change in Hb from baseline at Week 6		6 weeks after baseline	No
Secondary	Change in Hb from baseline at Week 9		9 weeks after baseline	No
Secondary	Change in Hb from baseline at Week 12		12 weeks after baseline	No