Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in… (NCT02940860) | Clinical Trial Compass
CompletedPhase 3
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
United States1,538 participantsStarted 2016-11-29
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women, ≥ 18 years
✓. Hb ≤ 11 g/dL
✓. 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
✓. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
✓. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
✓. Willingness to participate and signing the informed consent form
Exclusion criteria
✕. Anaemia predominantly caused by factors other than IDA
✕. Hemochromatosis or other iron storage disorders
✕. Previous serious hypersensitivity reactions to any IV iron compounds
✕. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
✕. Undergoing dialysis for treatment of CKD
✕. Planned surgical procedure within the trial period
What they're measuring
1
Change in Hemoglobin (Hb) From Baseline to Week 8
Timeframe: Baseline to week 8
2
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions