456
Participants
Start Date
April 30, 2007
Primary Completion Date
July 31, 2009
Study Completion Date
September 30, 2009
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 Sites, Buenos Aires
Research Site, Bad Nauheim
Research Site, Berlin
Research Site, Göttingen
Research Site, Hanover
Research Sites, Heidelberg
Research Site, Herford
Research Site, Herne
Research Site, Kiel
Research Site, München
Research Site, Athens
Research Site, Heraklion
Research Site, Ascoli Piceno
Research Site, Pavia
Research Site, Rome
Research Site, Vicenza
Research Site, Stavanger
Research Site, Bialystok
Research Site, Krakow
Research Site, Opole
Research Site, Piotrkow Trybunalski
Research Site, Siedlce
Research Site, Torun
Research Sites, Warsaw
Research Site, Wałbrzych
Research Site, Wroclaw
Research Site, Włocławek
Research Site, Zabrze
Research Site, Brasov
Research Sites, Bucharest
Reserach Site, Craiova
Research Sites, Târgu Mureş
Reserach Sites, Moscow
Resarch Sites, Saint Petersburg
Research Sites, Veliky Novgorod
Research Site, Alicante
Research Sites, Barcelona
Research Site, Bilbao
Research Site, Madrid
Research Site, Valencia
Research Site, Dnipropetrovsk
Research Site, Donetsk
Research Site, Kharkiv
Research Sites, Kiev
Research Site, Lviv
Research Site, Mykolayiv
Research Site, Odesa
Research Site, Zaporizhzhya
Lead Sponsor
Collaborators (1)
Vifor Pharma
INDUSTRY
Syneos Health
OTHER
ClinStar, LLC
INDUSTRY