122
Participants
Start Date
October 30, 2017
Primary Completion Date
May 29, 2018
Study Completion Date
May 29, 2018
Iron isomaltoside/ferric derisomaltose
"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg)."
Ferric carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
Pharmacosmos Investigational Site, Winston-Salem
Pharmacosmos Investigational Site, Raleigh
Pharmacosmos Investigational Site, Morehead City
Pharmacosmos Investigational Site, Orlando
Pharmacosmos Investigational Site, Miami Lakes
Pharmacosmos Investigational Site, Doral
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Muscle Shoals
Pharmacosmos investigational Site, Flint
Pharmacosmos Investigational Site, Oak Brook
Pharmacosmos Investigational Site, St Louis
Pharmacosmos Investigational Site, Idaho Falls
Pharmacosmos Investigational Site, Albuquerque
Pharmacosmos Investigational Site, Las Vegas
Lead Sponsor
Pharmacosmos A/S
INDUSTRY