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

Launched by VIFOR PHARMA · Oct 13, 2009

Keywords

ClinConnect Summary

After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.

1. FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.
2. FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.
3. Daily oral iron with 200 mg iron/day (100 mg twice daily)

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age.
• • 2. NDD-CKD subjects with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m2 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 ≥15 mL/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 as part of routine medical care was used.
• • 5. Any single serum ferritin \<100 mcg/L or \<200 mcg/L with TSAT \<20% within 4 weeks of randomisation. 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 any medically acceptable assessment, prior to randomisation.
• • 8. Before any study specific procedure, the appropriate written informed consent must have been obtained.
• Exclusion Criteria:
• • 1. History of acquired iron overload.
• • 2. Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate.
• • 3. Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress.
• • 4. Screening TSAT \>40%.
• • 5. Known active infection, C-reactive protein \>20 mg/L, clinically significant overt bleeding, active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).
• • 6. History of chronic alcohol abuse (alcohol consumption \>40 g/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 (HIV)/acquired immunodeficiency syndrome or active hepatitis B or C virus infection.
• • 9. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with 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 the screening period).
• • 11. Oral iron therapy at doses \>100 mg/day dosing must have been discontinued at least 1 week prior to randomisation. If subject had received this therapy for \>3 months (at doses \>100 mg/day) then subject was not eligible. Ongoing use of multivitamins containing 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 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, would have made participation unacceptable.
• • 20. Subject was not using adequate contraceptive precautions.
• • 21. Subject of childbearing potential was evidently pregnant (e.g., positive human chorionic 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 since ending other investigational device or drug studies, or subject was receiving other investigational 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 give written informed consent and/or to comply with study procedures.