chronic renal anemia
Conditions
Interventions
Product Name: C.E.R.A
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: RO
Sponsors
Roche Pharma (Schweiz) AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age 18 years or older 3. Chronic renal anaemia 4. Haemoglobin concentration in the country specific target range (Switzerland: between 11 g/dL and 13 g/dL; Austria: between 10 g/dL and 12 g/dL) 5. Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Transfusion of red blood cells during the previous 2 months 2. Poorly controlled hypertension at investigator’s discretion 3. Significant acute or chronic bleeding such as overt gastrointestinal bleeding 4. Active malignant disease (except non-melanoma skin cancer) 5. Haemolysis: haptoglobin 500 x 109/L or <100 x 109/L 10. Pure red cell aplasia 11. Epileptic seizure during previous 6 months 12. Active infection or inflammation at investigator's discretion 13. Congestive heart failure (NYHA Class IV) 14. Myocardial infarction or stroke. Severe or unstable coronary artery disease, severe liver disease at investigator’s discretion during the previous 3 months 15. Uncontrolled or symptomatic secondary hyperparathyroidism at investigator’s discretion 16. Pregnancy or lactation period 17. Women of childbearing potential without effective contraception 18. Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months 19. Life expectancy <12 months 20. Planned (date) elective surgery during the study period except for 21. cataract surgery 22. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication 23. Temporary (untunneled) dialysis access catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long term maintenance of haemoglobin levels, with once-monthly intravenous administration of C.E.R.A. in hemodialysis patients with chronic renal anaemia.;Secondary Objective: - to evaluate the safety and tolerability of C.E.R.A. once-monthly in the treatment of anaemia in patients with chronic kidney disease - to assess the fluctuation of individual haemoglobin levels.;Primary end point(s): The proportion of patients maintaining average haemoglobin concentration during the EEP within the in the country specific target range (for Switzerland between 11 g/dL and 13 g/dL and for Austria between 10 g/dL and 12 g/dL) OR +/- 1 g/dL of the reference haemoglobin concentration. | — |
Countries
Austria
Outcome results
None listed