NCT01213992View on ClinicalTrials.gov

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

November 30, 2012

Conditions
Non-dialysis Dependent Chronic Kidney Disease
Interventions
DRUG

Iron isomaltoside 1000

Single dose of 500 mg administered as a bolus undiluted over 2 min.

DRUG

Iron isomaltoside 1000

Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride

Sponsors

Lead Sponsor

Pharmacosmos A/S
All Listed Sponsors
lead

Pharmacosmos A/S

INDUSTRY