Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
Condition: Iron Deficiency Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Monofer; Iron Sulphate
Intervention description: Infusion or injections; Oral intake
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to determine the effects of an investigational drug Monofer in subjects
      with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron
      deficiency anaemia (IDA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women, aged more than 18 years.

          2. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.

          3. Hb < 11.0 g/dL (6.80 mmol/L)

          4. Either or both of the following iron stores indicators below target {Serum ferritin <
             100 ug/l and Transferrin saturation (TfS)<20%}.

          5. Life expectancy beyond 12 months by Principal Investigator's judgement.

          6. Willingness to participate after informed consent and any authorization as required by
             local law ( e.g. Protected Health Information [PHI] for North America).

        Exclusion Criteria:

          1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency
             (according to Principal Investigator's judgment).

          2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and
             haemosiderosis).

          3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or
             disaccharide complexes or to iron sulphate or any excipients of the study drug.

          4. Subjects with history of multiple allergies.

          5. Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3
             times upper normal limit).

          6. Active acute or chronic infections ((assessed by clinical judgment), supplied with
             White Blood Cells (WBC) and C-Reactive Protein (CRP)).

          7. Rheumatoid arthritis with symptoms or signs of active joint inflammation.

          8. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least
             12 months must have elapsed since last menstruation), surgically sterile, or women of
             child bearing potential must use one of the following contraceptives during the whole
             study period and after the study has ended for at least 5 times plasma biological
             half-life of the investigational medicinal product (5 days): Contraceptive pills,
             intrauterine devices (IUD), contraceptive depot injections (prolonged-release
             gestagen), subdermal implantation, vaginal ring, and transdermal patches).

          9. Extensive active bleeding necessitating blood transfusion.

         10. Planned elective surgery during the study.

         11. Participation in any other clinical study within 3 months prior to screening.

         12. Known intolerance to oral iron treatment.

         13. Untreated B12 or folate deficiency.

         14. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening
             visit.

         15. ESA treatment within 8 weeks prior to screening visit.

         16. Serum ferritin > 500 µg/L.

         17. Any other medical condition that, in the opinion of Principal Investigator, may cause
             the subject to be unsuitable for the completion of the study or place the subject at
             potential risk from being in the study or interfere with study drug evaluation.
             Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled
             Diabetes Mellitus.

         18. Body weight < 30 kilograms.