Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with
 iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD)
 and iron deficiency anaemia (IDA).
Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such
 as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL)
 burden on the subjects. Therapy of these subjects includes treating the underlying cause of
 IDA and restoring haemoglobin (Hb) concentration and iron stores.

 This study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose
 compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney
 disease (NDD-CKD) and iron deficiency anaemia (IDA).

 The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric
 derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and
 repeated according to standard practice or physician choice up to a maximum of five times
 within the first two weeks starting at baseline; a cumulative dose of 1000 mg was
 recommended). The study subjects were monitored for up to 8 weeks from baseline.
Inclusion Criteria includes:

 1. Men and women, ≥ 18 years

 2. Hb ≤ 11 g/dL

 3. Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at
 screening (as calculated by modification of diet in renal disease (MDRD)), or (ii)
 Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney
 damage as indicated by abnormalities in urine composition per medical history and/or
 intermediate/high risk of cardio-vascular disease based on the Framingham model

 4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30
 %

 5. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks
 before randomisation

 6. Willingness to participate and signing the informed consent form

 Exclusion Criteria includes:

 1. Anaemia predominantly caused by factors other than IDA

 2. Hemochromatosis or other iron storage disorders

 3. Previous serious hypersensitivity reactions to any IV iron compounds

 4. Prior to screening or during the trial period; has or will be treated with a red blood
 cell transfusion, radiotherapy, and/or chemotherapy

 5. Undergoing dialysis for treatment of CKD

 6. Planned surgical procedure within the trial period

 7. Decompensated liver cirrhosis or active hepatitis

 8. Alcohol or drug abuse within the past 6 month.

 9. Pregnant or nursing women.