Conditions: Iron Deficiency Anemia Kidney Disease
Keywords: Iron deficiency anemia Chronic kidney disease Feraheme Ferumoxytol Iron sucrose IDA CKD Venofer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

Detailed description:

Arms:
arm 1: Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g). arm 2: Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

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

Protocol document: