35
Participants
Start Date
December 31, 2008
Primary Completion Date
October 31, 2009
Study Completion Date
January 31, 2011
Ferinject ® (Ferric carboxymaltose)
"Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.~After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase)."
Normal saline (0.9%)
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.
Research Site, Copenhagen S
Research Site, Esbjerg
Research Site, Fredericia
Research Site, Glostrup Municipality
Research Site, Hellerup
Research Site, Herning
Research Site, Hilleroed
Research Site, Svendborg
Research Site, Boulogne
Research Site, Dijon
Research Site, Lyon
Research Site, Montpellier
Research Site, Nantes
Research Site, Pontoise
Research Site, Rennes
Research Site, Saintes
Research Site, Strasbourg
Research Site, Cologne
Research Site, Düren
Research Site, Frankfurt
Research Site, Homburg/Saar
Research Site, Mainz
Research Site, Würzburg
Research Site, Afula
Research Site, Ashkelon
Research Site, Haifa
Research Site, Holon
Research Site, Jerusalem
Research Site, Kfar Saba
Research Site, Rehovot
Research Site, Safed
Research Site, Tel Aviv
Research Site, Tel Litwinsky
Research Site, 's-Hertogenbosch
Research Site, Amsterdam
Research Site, Eindhoven
Research Site, Heerenveen
Research Site, Leiden
Research Site, Nieuwegein
Research Site, Tilburg
Research Site, Utrecht
Lead Sponsor
Socar Research SA
NETWORK
Vifor Pharma
INDUSTRY