A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

PHASE3CompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

December 31, 2013

Conditions
Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Interventions
DRUG

Monofer

Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

DRUG

Iron sucrose

Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Trial Locations (1)

Unknown

Jatin Kothari, Mumbai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacosmos A/S

INDUSTRY

NCT01222884 - A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D | Biotech Hunter | Biotech Hunter