Conditions: Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 351
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection arm 2: Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Interventions: intervention 1: Monofer intervention 2: Iron sucrose
Intervention descriptions: intervention 1: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes intervention 2: 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

Protocol document: