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

Anaemia Clinical Trial

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

Status Completed

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.

Clinical Trial 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

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

• NCT number: NCT01131624
• Study type: Interventional
• Source: Vifor Inc.
• Status: Completed
• Phase: Phase 3
• Start date: May 2010
• Completion date: April 2015