Ferric Carboxymaltose Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent CKD (FIND-CKD)

Inclusion Criteria:

1. NDD-CKD subjects with an eGFR ≤60ml/min/1.73m2 using MDRD calculation
2. NDD-CKD subjects with an eGFR loss ≤12ml/min/1.73m2 per year (based on at least 2 values over at least 4 weeks prior to randomisation ideally 3 values over at least 3 months) and a predicted eGFR ≥15ml/min/1.73m2 in 1 year. If more than 3 eGFR values are available in the 2-year time period prior to randomisation, the predicted loss should be calculated using 3 appropriately representative values. If predicted eGFR decline ≤12ml/min/1.73m2 per year then subject may be included
3. Hb between 9 and 11g/dL within 4 weeks of randomisation. Note A value taken as part of routine medical may be used
4. Serum ferritin <100mcg/L or <200mcg/L with TSAT <20% within 4 weeks of randomisation. Note Measurements taken as part of routine medical care may be used
5. ESA naïve (no exposure 4 months prior to randomisation)
6. Females of childbearing potential must have a negative pregnancy test prior to randomisation
7. Before any study-specific procedure the appropriate written informed consent must be obtained

Exclusion Criteria:

1. History of acquired iron overload
2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Note subjects with hypersensitivity to other forms of iron will be permitted to participate
3. Documented history of discontinuing oral iron products due to significant GI distress
4. Screening TSAT >40%
5. Known active infection, C-reactive protein >20mg/L, clinically significant overt bleeding, active malignancy
6. History of chronic alcohol abuse (alcohol consumption >40g/day)
7. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range
8. Active human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B or C virus infection
9. Anaemia due to reasons other than iron deficiency. Subjects with treated Vitamin B12 or folic acid deficiency are permitted
10. IV iron and/or blood transfusion in previous 30 days prior to screening
11. Oral iron therapy at doses >100mg/day in previous 1 week prior to randomisation and/or patients who have been continuously treated with >100mg/day of oral iron for the last 3 months. Upon randomisation the oral iron therapy must be discontinued. Note Ongoing use of multivitamins containing iron are permitted
12. Immunosuppressive therapy that may lead to anaemia. Note Steroid therapy is permitted
13. Currently requiring renal dialysis
14. Anticipated dialysis or transplant during the study
15. Anticipated need for surgery that may result in significant bleeding (>100ml)
16. Currently suffering from chronic heart failure NYHA Class IV
17. >160mmHg systolic pressure or >100mmHg diastolic pressure
18. Acute coronary syndrome or stroke within the 3 months prior to screening
19. Currently suffering from concomitant severe psychiatric disorders or other conditions which in the opinion of the Investigator make participation unacceptable
20. Subject is not using adequate contraceptive precautions. Adequate contraceptive precautions are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or postmenopausal defined as amenorrhea for at least 1 year
21. Subject of childbearing potential is evidently pregnant or is breastfeeding
22. Body weight <35kg
23. Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug studies or subject receiving other investigational agents
24. Subject will not be available for follow up assessment
25. Subject has any kind of disorder that compromises the ability to give written informed consent and/or comply with study procedures