NCT03238911 - Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia | Biotech Hunter

Enrollment

123

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

June 19, 2018

Study Completion Date

June 19, 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.~Ferric carboxymaltose was administered as 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg)."

Trial Locations (16)

17605

Pharmacosmos Investigational Site, Lancaster

20176

Pharmacosmos Investigational Site, Leesburg

33125

Pharmacosmos Investigational Site, Miami

33126

Pharmacosmos Investigational Site 1, Miami

Pharmacosmos Investigational Site 2, Miami

33143

Pharmacosmos Investigational Site, Miami

33144

Pharmacosmos Investigational Site, Miami

33759

Pharmacosmos Investigational Site, Clearwater

46202

Pharmacosmos Investigational Site, Indianapolis

67206

Pharmacosmos Investigational Site, Wichita

70001

Pharmacosmos Investigational Site, Metairie

77024

Pharmacosmos Investigational Site, Houston

84058

Pharmacosmos Investigational Site, Orem

90036

Pharmacosmos Investigational Site, Los Angeles

92704

Pharmacosmos Investigational Site, Santa Ana

95831

Pharmacosmos Investigational Site, Sacramento