Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,512

Participants

Timeline

Start Date

November 8, 2016

Primary Completion Date

March 28, 2018

Study Completion Date

March 28, 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 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."

DRUG

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."

Trial Locations (114)

10016

Pharmacosmos Investigational Site, New York

11235

Brooklyn

11733

Pharmacosmos Investigational Site 1, East Setauket

Pharmacosmos Investigational Site 2, East Setauket

19046

Pharmacosmos Investigational Site, Jenkintown

20817

Pharmacosmos Investigational Site, Bethesda

21204

Pharmacosmos Investigational Site, Towson

21740

Pharmacosmos Investigational Site, Hagerstown

23320

Pharmacosmos Investigational Site, Chesapeake

28401

Pharmacosmos Investigational Site, Wilmington

28403

Pharmacosmos Investigational Site, Wilmington

29209

Pharmacosmos Investigational Site, Columbia

29572

Pharmacosmos Investigational Site, Myrtle Beach

32024

Pharmacosmos Investigational Site, Lake City

32204

Pharmacosmos Investigational Site, Jacksonville

33012

Pharmacosmos Investigational Site, Hialeah

33014

Pharmacosmos Investigational Site 1, Miami Lakes

Pharmacosmos Investigational Site 2, Miami Lakes

Pharmacosmos Investigational Site, Miami Lakes

33015

Pharmacosmos Investigational Site, Hialeah

Pharmacosmos Investigational Site, Miami

33016

Pharmacosmos Investigational Site, Hialeah

33024

Pharmacosmos Investigational Site, Hollywood

33126

Pharmacosmos Investigational Site, Miami

33130

Pharmacosmos Investigational Site, Miami

33135

Pharmacosmos Investigational Site, Miami

33144

Pharmacosmos Investigational Site 1, Miami

Pharmacosmos Investigational Site 2, Miami

33147

Pharmacosmos Investigational Site, Miami

33155

Pharmacosmos Investigational Site, Miami

33157

Pharmacosmos Investigational Site, Palmetto Bay

33165

Pharmacosmos Investigational Site, Miami

33166

Pharmacosmos Investigational Site 1, Doral

Pharmacosmos Investigational Site 2, Doral

33172

Pharmacosmos Investigational Site, Doral

33173

Pharmacosmos Investigational Site, Miami

33174

Pharmacosmos Investigational Site, Miami

33180

Pharmacosmos Investigational Site, Aventura

33185

Pharmacosmos Investigational Site, Miami

33308

Pharmacosmos Investigational Site, Fort Lauderdale

33324

Pharmacosmos Investigational Site, Plantation

33409

Pharmacosmos Investigational Site, West Palm Beach

33426

Pharmacosmos Investigational Site, Boynton Beach

33461

Pharmacosmos Investigational Site, Lake Worth

33467

Pharmacosmos Investigational Site, Lake Worth

34102

Pharmacosmos Investigational Site 1, Naples

Pharmacosmos Investigational Site 2, Naples

34741

Pharmacosmos Investigational Site, Kissimmee

35205

Pharmacosmos Investigational Site, Birmingham

35976

Pharmacosmos Investigational Site, Guntersville

36305

Pharmacosmos Investigational Site, Dothan

37067

Pharmacosmos Investigational Site, Franklin

37404

Pharmacosmos Investigational Site, Chattanooga

37923

Pharmacosmos Investigational Site, Knoxville

38104

Pharmacosmos Investigational Site, Memphis

42303

Pharmacosmos Investigational Site, Owensboro

43231

Pharmacosmos Investigational Site, Columbus

44718

Pharmacosmos Investigational Site, Canton

45206

Pharmacosmos Investigational Site, Cincinnati

45431

Pharmacosmos Investigational Site, Beavercreek

45459

Pharmacosmos Investigational Site, Centerville

47802

Pharmacosmos Investigational Site, Terre Haute

48085

Pharmacosmos Investigational Site, Troy

48604

Pharmacosmos Investigational Site, Saginaw

49525

Pharmacosmos Investigational Site, Grand Rapids

60435

Pharmacosmos Investigational Site, Joliet

60463

Pharmacosmos Investigational Site, Palos Heights

61820

Pharmacosmos Investigational Site, Champaign

63031

Pharmacosmos Investigational Site, Florissant

67214

Pharmacosmos Investigational Site, Wichita

68134

Pharmacosmos Investigational Site, Omaha

70006

Pharmacosmos Investigational Site, Metairie

70072

Pharmacosmos Investigational Site, Marrero

70125

Pharmacosmos Investigational Site, New Orleans

70809

Pharmacosmos Investigational Site, Baton Rouge

71103

Pharmacosmos Investigational Site, Shreveport

72204

Pharmacosmos Investigational Site, Little Rock

72205

Pharmacosmos Investigational Site, Little Rock

73069

Pharmacosmos Investigational Site, Norman

74136

Pharmacosmos Investigational Site, Tulsa

75110

Pharmacosmos Investigational Site, Corsicana

75115

Pharmacosmos Investigational Site, DeSoto

77030

Pharmacosmos Investigational Site, Houston

77079

Pharmacosmos Investigational Site, Houston

77099

Pharmacosmos Investigational Site, Houston

77521

Pharmacosmos Investigational Site, Baytown

77702

Pharmacosmos Investigational Site, Beaumont

78215

Pharmacosmos Investigational Site, San Antonio

78217

Pharmacosmos Investigational Site, San Antonio

78503

Pharmacosmos Investigational Site, McAllen

78704

Pharmacosmos Investigational Site, Austin

84405

Pharmacosmos Investigational Site, Ogden

85018

Pharmacosmos Investigational Site, Phoenix

89109

Pharmacosmos Investigational Site, Las Vegas

90603

Pharmacosmos Investigational Site, Whittier

90806

Pharmacosmos Investigational Site, Long Beach

91324

Pharmacosmos Investigational Site 1, Northridge

Pharmacosmos Investigational Site 2, Northridge

91942

Pharmacosmos Investigational Site 1, La Mesa

Pharmacosmos Investigational Site 2, La Mesa

91950

Pharmacosmos Investigational Site, National City

92056

Pharmacosmos Investigational Site, Oceanside

92078

Pharmacosmos Investigational Site, San Marcos

92103

Pharmacosmos Investigational Site, San Diego

92117

Pharmacosmos Investigational Site, San Diego

92377

Pharmacosmos Investigational Site, Rialto

92501

Pharmacosmos Investigational Site, Riverside

92610

Pharmacosmos Investigational Site, Foothill Ranch

93536

Pharmacosmos Investigational Site, Quartz Hill

98405

Pharmacosmos Investigational Site, Tacoma

06062

Pharmacosmos Investigational Site, Plainville

02720

Pharmacosmos Investigational Site, Fall River

07753

Pharmacosmos Investigational Site, Neptune City

08536

Pharmacosmos Investigational Site, Plainsboro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacosmos A/S

INDUSTRY