1,512
Participants
Start Date
November 8, 2016
Primary Completion Date
March 28, 2018
Study Completion Date
March 28, 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 set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes."
Iron sucrose
"Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial.~Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended."
Pharmacosmos Investigational Site, New York
Brooklyn
Pharmacosmos Investigational Site 1, East Setauket
Pharmacosmos Investigational Site 2, East Setauket
Pharmacosmos Investigational Site, Jenkintown
Pharmacosmos Investigational Site, Bethesda
Pharmacosmos Investigational Site, Towson
Pharmacosmos Investigational Site, Hagerstown
Pharmacosmos Investigational Site, Chesapeake
Pharmacosmos Investigational Site, Wilmington
Pharmacosmos Investigational Site, Wilmington
Pharmacosmos Investigational Site, Columbia
Pharmacosmos Investigational Site, Myrtle Beach
Pharmacosmos Investigational Site, Lake City
Pharmacosmos Investigational Site, Jacksonville
Pharmacosmos Investigational Site, Hialeah
Pharmacosmos Investigational Site 1, Miami Lakes
Pharmacosmos Investigational Site 2, Miami Lakes
Pharmacosmos Investigational Site, Miami Lakes
Pharmacosmos Investigational Site, Hialeah
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Hialeah
Pharmacosmos Investigational Site, Hollywood
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site 1, Miami
Pharmacosmos Investigational Site 2, Miami
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Palmetto Bay
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site 1, Doral
Pharmacosmos Investigational Site 2, Doral
Pharmacosmos Investigational Site, Doral
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Aventura
Pharmacosmos Investigational Site, Miami
Pharmacosmos Investigational Site, Fort Lauderdale
Pharmacosmos Investigational Site, Plantation
Pharmacosmos Investigational Site, West Palm Beach
Pharmacosmos Investigational Site, Boynton Beach
Pharmacosmos Investigational Site, Lake Worth
Pharmacosmos Investigational Site, Lake Worth
Pharmacosmos Investigational Site 1, Naples
Pharmacosmos Investigational Site 2, Naples
Pharmacosmos Investigational Site, Kissimmee
Pharmacosmos Investigational Site, Birmingham
Pharmacosmos Investigational Site, Guntersville
Pharmacosmos Investigational Site, Dothan
Pharmacosmos Investigational Site, Franklin
Pharmacosmos Investigational Site, Chattanooga
Pharmacosmos Investigational Site, Knoxville
Pharmacosmos Investigational Site, Memphis
Pharmacosmos Investigational Site, Owensboro
Pharmacosmos Investigational Site, Columbus
Pharmacosmos Investigational Site, Canton
Pharmacosmos Investigational Site, Cincinnati
Pharmacosmos Investigational Site, Beavercreek
Pharmacosmos Investigational Site, Centerville
Pharmacosmos Investigational Site, Terre Haute
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Pharmacosmos Investigational Site, Grand Rapids
Pharmacosmos Investigational Site, Joliet
Pharmacosmos Investigational Site, Palos Heights
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Pharmacosmos Investigational Site, Florissant
Pharmacosmos Investigational Site, Wichita
Pharmacosmos Investigational Site, Omaha
Pharmacosmos Investigational Site, Metairie
Pharmacosmos Investigational Site, Marrero
Pharmacosmos Investigational Site, New Orleans
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Pharmacosmos Investigational Site, Shreveport
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Pharmacosmos Investigational Site, Little Rock
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Pharmacosmos Investigational Site, Houston
Pharmacosmos Investigational Site, Houston
Pharmacosmos Investigational Site, Houston
Pharmacosmos Investigational Site, Baytown
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Pharmacosmos Investigational Site, San Antonio
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Pharmacosmos Investigational Site 1, Northridge
Pharmacosmos Investigational Site 2, Northridge
Pharmacosmos Investigational Site 1, La Mesa
Pharmacosmos Investigational Site 2, La Mesa
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Pharmacosmos Investigational Site, San Diego
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Pharmacosmos Investigational Site, Foothill Ranch
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Pharmacosmos Investigational Site, Tacoma
Pharmacosmos Investigational Site, Plainville
Pharmacosmos Investigational Site, Fall River
Pharmacosmos Investigational Site, Neptune City
Pharmacosmos Investigational Site, Plainsboro
Lead Sponsor
Pharmacosmos A/S
INDUSTRY