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

Sponsor

Vifor Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01131624

Collaborator

Pierrel Research Europe GmbH (Industry)

252

Enrollment

Locations

Arms

Duration (Months)

12.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anaemia	Drug: ferrous sulphate Drug: Ferinject	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Ferric carboxymaltose FCM
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 Names: Oral Iron

Arm

Intervention/Treatment

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 Names:

Ferric carboxymaltose

FCM

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 Names:

Oral Iron

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Northern Hospital	Epping	Victoria	Australia	3076
2	Vivantes Klinikum Neukölln, Klinikum für Geburtsmedizin	Berlin		Germany	12351
3	Klinik Für Frauenheilkunde und Geburtshilfe Universitätsklinikum Marburg	Marburg		Germany	35043
4	Perinatalzentrum, Klinikum Innenstadt LMU	München		Germany	80337
5	Kvinnokliniken, Falu lasarett	Falun		Sweden	SE-791
6	Kvinnokliniken, University Hospital	Lund		Sweden	SE-221
7	Kvinnokliniken, Karolinska University Hospital	Stockholm		Sweden	17176
8	Karolinska Universitetssjukhuset Huddinge, Centrum för fostermedicin KK	Stockholm		Sweden	SE-141
9	University Hospital, Dept of obstetrics and gynecology Uppsala	Uppsala		Sweden	SE-751
10	Universitätsspital Basel, Geburtshilfe und Schwangerschaftsmedizin Frauenklinik	Basel		Switzerland	4031
11	Inselspital, Department of Obstetrics and Gynecology	Bern		Switzerland	3010
12	Humboldtstrasse	Bern		Switzerland	3013
13	HUG, Département de Gynécologie-Obstétrique	Genève		Switzerland	1211
14	CHUV, Département de Gynécologie-Obstétrique	Lausanne		Switzerland	1011
15	OR Lugano, sede Ospedale Civico, Clinica ginecologia ostetricia	Lugano		Switzerland	6900
16	Universitätsspital Zürich, Departement Frauenheilkunde	Zürich		Switzerland	8091
17	Cukurova University Hospital	Adana		Turkey	01330
18	Istanbul Uni. Ist. Med. Faculty	Istanbul		Turkey	34093
19	Zeynep Kamil Hospital, Arakiyeci Haci Mehmet Mahallesi.	Istanbul		Turkey	34668
20	Dr. Kutfi Kirdar Kartal Research and Education Hospital	Istanbul		Turkey	34890

Sponsors and Collaborators

Vifor Pharma
Pierrel Research Europe GmbH

Investigators

Principal Investigator: Christian Breymann, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vifor Pharma

ClinicalTrials.gov Identifier:

NCT01131624

Other Study ID Numbers:

FER-ASAP-2009-01

First Posted:

May 27, 2010

Last Update Posted:

May 29, 2015

Last Verified:

Dec 1, 2014

Keywords provided by Vifor Pharma

Iron deficiency

Additional relevant MeSH terms:

Anemia

Anemia, Iron-Deficiency

Study Results

No Results Posted as of May 29, 2015