Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Condition: Iron Deficiency Anaemia; Iron Deficiency Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Iron isomaltoside/ferric derisomaltose; Iron sucrose
Intervention description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.; Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes 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.
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated; Iron isomaltoside 1000
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1538.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron Deficiency Anaemia; Iron Deficiency Anemia; IDA; Chronic Kidney Disease; CKD; Iron isomaltoside; Ferric derisomaltose; Monofer; Monoferric; Monover; Monofar; Monoferro

Summary:

      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).
    

Eligibility criteria:

        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.