Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Inclusion Criteria:

1. At least 18 years of age.

2. NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2 using modification of diet in renal disease 4 (MDRD-4) calculation.

3. NDD-CKD subjects with an eGFR loss ≤12 mL/min/1.73 m2/year and a predicted eGFR of ≥15mL/min/1.73 m2 in 12 months.

4. Any single Hb between 9 and 11 g/dL within 4 weeks of randomisation. A value taken aspart of routine medical care was used.

5. Any single serum ferritin <100 mcg/L or <200 mcg/L with TSAT <20% within 4 weeks ofrandomisation. Measurements taken as part of routine medical care were used.

6. ESA naïve; no exposure to ESA in last 4 months prior to randomisation.

7. Females of childbearing potential must have had a negative pregnancy test, using anymedically acceptable assessment, prior to randomisation.

8. Before any study specific procedure, the appropriate written informed consent musthave been obtained.

Exclusion Criteria:

1. History of acquired iron overload.

2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjectswith hypersensitivity to other forms of iron were permitted to participate.

3. Documented history of discontinuing oral iron products due to significantgastrointestinal (GI) distress.

4. Screening TSAT >40%.

5. Known active infection, C-reactive protein >20 mg/L, clinically significant overtbleeding, active malignancy (i.e., clinical evidence of current malignancy or not instable remission for at least 5 years since completion of last treatment withexception of basal cell or squamous cell carcinoma of the skin, and cervicalintraepithelial neoplasia).

6. History of chronic alcohol abuse (alcohol consumption >40 g/day).

7. Chronic liver disease and/or screening alanine transaminase or aspartate transaminaseabove 3 times the upper limit of the normal range.

8. Active human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome or activehepatitis B or C virus infection.

9. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjectswith treated Vitamin B12 or folic acid deficiency were permitted.

10. IV iron and/or blood transfusion in previous 30 days prior to screening (or during thescreening period).

11. Oral iron therapy at doses >100 mg/day dosing must have been discontinued at least 1week prior to randomisation. If subject had received this therapy for >3 months (atdoses >100 mg/day) then subject was not eligible. Ongoing use of multivitaminscontaining iron was permitted.

12. Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide,azathioprine, or mycophenolate mofetil). Steroid therapy was permitted.

13. Currently requiring renal dialysis.

14. Anticipated dialysis or transplant during the study.

15. Anticipated need for surgery that may have resulted in significant bleeding (>100 mL).

16. Currently suffering from chronic heart failure New York Heart Association Class IV.

17. Poorly controlled hypertension (>160 mmHg systolic pressure or >100 mmHg diastolicpressure).

18. Acute coronary syndrome or stroke within the 3 months prior to screening.

19. Currently suffering from concomitant, severe psychiatric disorders or other conditionswhich, in the opinion of the Investigator, would have made participation unacceptable.

20. Subject was not using adequate contraceptive precautions.

21. Subject of childbearing potential was evidently pregnant (e.g., positive humanchorionic gonadotropin test) or was breast feeding.

22. Body weight <35 kg.

23. Subject currently was enrolled in or had not yet completed at least 30 days sinceending other investigational device or drug studies, or subject was receiving otherinvestigational agent(s).

24. Subject would not be available for follow-up assessment.

25. Subject had any kind of disorder that compromised the ability of the subject to givewritten informed consent and/or to comply with study procedures.