Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

PHASE3CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

January 31, 2019

Primary Completion Date

December 22, 2020

Study Completion Date

January 29, 2021

Conditions
Iron Deficiency Anemia
Interventions
DRUG

Ferric carboxymaltose

Intravenous iron

DRUG

Ferrous Sulfate

oral iron therapy

Trial Locations (16)

10467

Tiga Pediatrics, PC, The Bronx

33122

International Research Partners, Inc., Doral

33155

Garden Medical Research, Inc., Miami

Miami Clinical Research, Miami

33166

ProHealth Research Center, Doral

South Florida Research Phase I-IV, Miami Springs

45229

Cincinnati Children's Hospital and Medical Center, Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children,Room 4340, Indianapolis

48723

Caro Health Plaza, Caro

63005

Galen Research, Chesterfield

72202

Arkansas Children's Hospital, Little Rock

76101

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine/Texas Children Hospital, Houston

78240

Tekton Research, San Antonio

84058

Aspen Clinical Research, Orem

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY