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

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Conditions

• Chronic Kidney Disease Stage 5 (Dialysis Dependent)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2010-10-18
• Last updated: 2015-12-02
• Results posted: 2015-07-24

Locations

1 site across 1 country: India