Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

October 30, 2017

Primary Completion Date

May 29, 2018

Study Completion Date

May 29, 2018

Conditions
Iron Deficiency AnaemiaIron Deficiency Anemia
Interventions
DRUG

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)."

DRUG

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).

Trial Locations (15)

27103

Pharmacosmos Investigational Site, Winston-Salem

27607

Pharmacosmos Investigational Site, Raleigh

28557

Pharmacosmos Investigational Site, Morehead City

32819

Pharmacosmos Investigational Site, Orlando

33014

Pharmacosmos Investigational Site, Miami Lakes

33122

Pharmacosmos Investigational Site, Doral

33144

Pharmacosmos Investigational Site, Miami

33165

Pharmacosmos Investigational Site, Miami

35661

Pharmacosmos Investigational Site, Muscle Shoals

48504

Pharmacosmos investigational Site, Flint

60523

Pharmacosmos Investigational Site, Oak Brook

63119

Pharmacosmos Investigational Site, St Louis

83404

Pharmacosmos Investigational Site, Idaho Falls

87102

Pharmacosmos Investigational Site, Albuquerque

89146

Pharmacosmos Investigational Site, Las Vegas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacosmos A/S

INDUSTRY