Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

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 bylocal 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 andhaemosiderosis).

3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- ordisaccharide 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) > 3times upper normal limit).

6. Active acute or chronic infections ((assessed by clinical judgment), supplied withWhite 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 ofchild bearing potential must use one of the following contraceptives during the wholestudy period and after the study has ended for at least 5 times plasma biologicalhalf-life of the investigational medicinal product (5 days): Contraceptive pills,intrauterine devices (IUD), contraceptive depot injections (prolonged-releasegestagen), 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 screeningvisit.

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 causethe subject to be unsuitable for the completion of the study or place the subject atpotential risk from being in the study or interfere with study drug evaluation.Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or UncontrolledDiabetes Mellitus.

18. Body weight < 30 kilograms.