Conditions: Iron Deficiency Anemia Treatment Chronic Kidney Disease(CKD)
Keywords: Iron deficiency anemia (IDA) chronic kidney disease (CKD) hemodialysis magnetic resonance imaging (MRI) ferumoxytol Feraheme
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 296
Healthy volunteers: no

Brief summary:
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Detailed description:
This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for the episodic treatment of IDA in hemodialysis subjects with CKD over a 1-year period. As part of this Main Study, an Oxidative Stress Substudy and an MRI Substudy were conducted. The Oxidative Stress Substudy, to be run concurrently with the initial TP of the Main Study, was to examine the varying degrees to which iron sucrose and ferumoxytol may or may not induce oxidative stress in vitro in subjects undergoing hemodialysis. The MRI Substudy, to be run concurrently with the Main Study and continue for an additional 11 months, was to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a 2-year period.

Arms:
arm 1: Intravenous (IV) iron arm 2: Intravenous (IV) iron

Interventions: intervention 1: Ferumoxytol intervention 2: Iron Sucrose
Intervention descriptions: intervention 1: IV Ferumoxytol intervention 2: IV Iron Sucrose

Protocol document: