Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

PHASE3CompletedINTERVENTIONAL

Enrollment

2,561

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

July 31, 2011

Study Completion Date

August 31, 2011

Conditions

Iron Deficiency AnemiaImpaired Renal Function

Interventions

DRUG

Ferric Carboxymaltose (FCM)

2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg

DRUG

Iron Sucrose (Venofer)

5 doses of 200 mg for a total cumulative dose of 1000 mg

Trial Locations (1)

Luitpold Pharmaceuticals, Inc., Norristown