Summary:
A Phase III, randomised, open label, comparative safety and efficacy trial of intravenous iron isomaltoside (Monofet) and iron sucrose in subjects with iron deficiency anemia and non-dialysis-dependent chronic kidney disease
Inclusion:
- Men or women 18 and older
- HB ≤ 11g/dL
- Chronic renal impairment
- Screening s-ferritin ≤ng/mL, or ≤ ng/mL if TSAT ≤30
- Either no ESAs or ESAs as a stable dose(+/-20%)4 weeks before randomization
Exclusions:
- Anemia predominantly caused by factors other than IDA
- Hemochromatosis or other iron storage disorders
- Known hypersensitivity reaction to any component of iron isomaltoside or iron sucrose
- Previous serious hypersensitivity reactions to any IV iron compounds
- During 30-day period prior to screening or during trial, has or will be treated with red blood cell transfusion, chemotherapy, and/or radiotherapy
Qualified Participants May Receive:
Participant will receive compensation for their time and travel.