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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01131624
Other study ID # FER-ASAP-2009-01
Secondary ID
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


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
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