A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

Inclusion Criteria:

1. Men or women, aged 18 years or greater.
2. Subjects diagnosed with CKD-5D and in hemodialysis therapy for at least 90 days.
3. Life expectancy beyond 12 months by Principal Investigator's judgment.
4. Willingness and ability to participate after informed consent and any authorization as required by local law.
5. Hb concentrations between 9.5 g/dL and 12.5 g/dL both at screening and at baseline (screening visit and baseline visit must be separated by at least 1 week).
6. Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to screening.
7. Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4 weeks.

Exclusion Criteria:

1. Anaemia caused primarily by factors other than renal related anaemia.
2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
3. Serum ferritin > 800 ng/ml.
4. Transferrin Saturation >35%.
5. Difference between screening Hb and baseline Hb of ≥ 1.0 g/dL.
6. History of drug hypersensitivity to iron sucrose or iron isomaltoside.
7. Known hypersensitivity to any excipients in the investigational drug products.
8. Patients with a history of two or more drug class allergies.
9. Liver cirrhosis or active hepatitis (alanine aminotransferase (ALT) > 3 times normal).
10. Acute or chronic infections (assessed by clinical judgment).
11. Rheumatoid arthritis with symptoms or signs of active inflammation.
12. Pregnancy or 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: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
13. Blood transfusion within the previous 12 weeks.
14. Planned elective surgery in the next 8 weeks.
15. Participation in any other clinical trial within the past 30 days, or if longer, where the study drug has not passed five half-lives prior to screening.
16. Untreated vitamin B12 or folate deficiency.
17. Diagnosis of Hepatitis B and/or C.
18. 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. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.