Status:
COMPLETED
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Lead Sponsor:
Vifor Pharma
Collaborating Sponsors:
American Regent, Inc.
ICON Clinical Research
Conditions:
Iron Deficiency Anaemia
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (N...
Detailed Description
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 intraveno...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- 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.
- 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.
- 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.
- 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.
- ESA naïve; no exposure to ESA in last 4 months prior to randomisation.
- Females of childbearing potential must have had a negative pregnancy test, using any medically acceptable assessment, prior to randomisation.
- Before any study specific procedure, the appropriate written informed consent must have been obtained.
Exclusion
- History of acquired iron overload.
- Known hypersensitivity reaction to any component of ferrous sulphate or FCM. Subjects with hypersensitivity to other forms of iron were permitted to participate.
- Documented history of discontinuing oral iron products due to significant gastrointestinal (GI) distress.
- Screening TSAT \>40%.
- 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).
- History of chronic alcohol abuse (alcohol consumption \>40 g/day).
- Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.
- Active human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome or active hepatitis B or C virus infection.
- Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with treated Vitamin B12 or folic acid deficiency were permitted.
- IV iron and/or blood transfusion in previous 30 days prior to screening (or during the screening period).
- 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.
- Immunosuppressive therapy that may have led to anaemia (e.g., cyclophosphamide, azathioprine, or mycophenolate mofetil). Steroid therapy was permitted.
- Currently requiring renal dialysis.
- Anticipated dialysis or transplant during the study.
- Anticipated need for surgery that may have resulted in significant bleeding (\>100 mL).
- Currently suffering from chronic heart failure New York Heart Association Class IV.
- Poorly controlled hypertension (\>160 mmHg systolic pressure or \>100 mmHg diastolic pressure).
- Acute coronary syndrome or stroke within the 3 months prior to screening.
- Currently suffering from concomitant, severe psychiatric disorders or other conditions which, in the opinion of the Investigator, would have made participation unacceptable.
- Subject was not using adequate contraceptive precautions.
- Subject of childbearing potential was evidently pregnant (e.g., positive human chorionic gonadotropin test) or was breast feeding.
- Body weight \<35 kg.
- 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).
- Subject would not be available for follow-up assessment.
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT00994318
Start Date
December 1 2009
End Date
February 1 2014
Last Update
May 20 2014
Active Locations (19)
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1
Trial Management Associates
Wilmington, North Carolina, United States, 28401
2
Gosford Hospital - Renal Research
Gosford, Australia, 2250
3
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin IV
Innsbruck, Austria, 6020
4
RHMS Baudour - Department of Nephrology and Dialysis
Baudour, Belgium, 7331