NCT01213992

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

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-Dialysis Dependent Chronic Kidney Disease (PK-CKD-03)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney Disease.

Conditions

• Non-dialysis Dependent Chronic Kidney Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2010-10-04
• Last updated: 2013-11-14