Iron deficiency anaemia in subjects with non-dialysis-dependent chronic kidney disease MedDRA version: 14.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease Sy
Conditions
Interventions
Trade Name: Ferinject®
Pharmaceutical Form: Infusion
INN or Proposed INN: Ferric carboxymaltose (FCM)
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Vifor Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion 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 (MDRD) calculation. 3. NDD-CKD subjects with an eGFR loss =12 mL/min/1.73 m² per year and a predicted eGFR of =15 mL/min/1.73 m2 in 12 months. The eGFR loss, defined as =12 mL/min/1.73 m2 per year, should be based on at least 2 appropriately representative values over at least 4 weeks prior to randomisation, ideally 3 values over at least 3 months. If this predicted eGFR decline is =12 mL/min/1.73 m2 per year then subject may be included (*). The predicted eGFR of =15 mL/min/1.73 m2 in 12 months should be estimated based on previous eGFR values. If more than 3 eGFR values are available in the 2-year time period prior to randomisation, the predicted eGFR at 12 months should be calculated using 3 appropriately representative values (which will also be recorded in the case report form (CRF)). 4. Any single Hb between 9 and 11 g/dL within 4 weeks of randomisation. Note: A value taken as part of routine medical care may be used. 5. Any single serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
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 gastrointestinal 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/acquired immunodeficiency syndrome OR active hepatitis B or C virus infection (known positive serology to HIV antibodies OR hepatitis B antigen, hepatitis C antibody with clinical signs of active hepatitis). 9. Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subject with treated Vitamin B12 or folic acid deficiency are permitted. 10. Intravenous 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 be discontinued at least 1 week prior to randomisation. If patient has received this therapy for greater than 3 months (at doses >100 mg/day) then subject is not eligible. Note: Ongoing use of multivitamins containing iron are permitted. 12. Immunosuppressive therapy that may lead to anaemia e.g., cyclophosphamide, azathioprine, mycophenolate mofetil, etc. 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 (>100 ml). 16. Currently suffering from chronic heart failure New York Heart Association (NYHA) 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, 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 (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron deficiency anaemia (IDA).; Primary end point(s): Time to the initiation of other anaemia management (e.g., ESA or transfusion) using Kaplan-Meier survival analyses. ;Timepoint(s) of evaluation of this end point: End of Study; Secondary Objective: To evaluate the potential to reduce ESA requirement for subjects receiving FCM (using targeted ferritin levels to determine dosing) or oral iron. To evaluate the long-term safety and tolerability of Ferinject and oral iron in the treatment of NDD-CKD subjects with IDA. To evaluate the health resource utilisation, quality of life (QoL) effects and economic burden of the treatment of NDD-CKD subjects with IDA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Cumulative ESA requirement over the study period. 2. Percentage of subjects requiring transfusion at anytime during the study. 3. Cumulative iron requirements and number of iron administrations over the study period. 4. Percentage of subjects with an increase of Hb =1 g/dL prior to any other anaemia management (e.g., ESA or transfusion). 5. Value change from baseline to end of study (for each visit) for the following parameters: - Haematological and iron parameters. - eGFR as calculated with the MDRD formula. 6. Percentage of subjects requiring dialysis at anytime during the study. 7. Change in health-related QoL over the study period using the SF-36. 8. Health resource utilisation over the study period calculated direct, indirect and total costs from 2 perspectives (payer’s and societal perspective). 9. Cost effectiveness of treatment options using relevant effectiveness parameters. 10. Percentage of subjects discontinuing the study drug due to intolerance. ; Timepoint(s) of evaluation of this end point: 1. End of Study 2. Duration of Study 3. End of Study 4. Every 4 weeks until Week 56 5. Every 4 weeks until Week 56 6. Duration of Study 7. End of Study 8. End of Study 9. End of Study 10. Duration of Study | — |
Countries
Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contacts
Public ContactMedical Information
Vifor Pharma Inc.
Outcome results
None listed