Chronic renal anemia MedDRA version: 9.1 Level: LLT Classification code 10058124 Term: Nephrogenic anemia
Conditions
Interventions
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol epoetin beta
Current Sponsor code: RO0503821
Other descriptive name: C.E.R.A
Concen
Sponsors
Roche (HELLAS) SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Age 18 years or older - Chronic renal anaemia - Haemoglobin concentration between 10.5 and 12.5 g/ dL - 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: - Transfusion of red red blood cells during the previous 2months - Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of epoetin alfa or darvepoetin alfa treatment in the previous 6 months - Significant acute or chronic bleeding such as overt gastrointestinal bleeding - Active malignant disease (except non-melanoma skin cancer) - Haemolysis - Haemoglobinpathies (e.g. homozygous sickle- cell disease, thalassemia of all types) - Folic acid deficiency - Vitamin B12 deficiency - Platelet count > 500 × 10[9]/ L or < 100 × 10[9]/ L - Pure red cell aplasia - Epileptic seizure during previous 6 months - Congestive heart feilure (NYHA Class IV) - Myocardial infraction or stroke, severe or unstable coronary artery diease, severe liver disease during the previous 3 months - Uncontrolled or symptomatic secondary hyperparathyroidism - Pregnancy or lactation period - Women of childbearing potential without effective contraception - Participation in a clinical trial or receipt of investigational compound or an investigational treatment during the previous 3 months - Planned (date) elective surgery during the study period except for - cataract surgery - Known hypersensitivity to recombinant human erythropoetin, polyethylene glycol or to any constituent of the study medication - 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 dialysis patients with chronic renal anaemia;Secondary Objective: To evauate the safety and tolerability of C.E.R.A. once monthly in the treatment of anaemia in patients with chronic kidney disease Additional: To explore associations between NT-proBNP levels and clinical outcomes observed during the study;Primary end point(s): The primary endpoint in this study will be the proportion of patients maintaining their mean haemoglobin concentration (g/ dL) within +/- 1 g/ dL of their reference Hb and between 10.5 and 12.5 g/ dL. | — |
Countries
Greece
Outcome results
None listed