Chronic renal anemia MedDRA version: 8.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia
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: R
Sponsors
Roche AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written informed consent - Age 18 years or older - Chronic renal anaemia - Haemoglobin concentration between 10.5 g/dl 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 blood cells during the previous 2 months - Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of darbepoetin 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 - Haemoglobinopathies (e.g homozygous sickle-cell disease, thalassemia of all types) - Folic acid deficiency - Vitamin B12 deficiency - Platelet count >500 x 109/L or <100 x 109/L - Pure red cell aplasia - Epileptic seizure during previous 6 months - Congestive heart failure (NYHA Class IV) - Myocardial infarction or stroke, severe or unstable coronary artery disease, 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 an investigational compound or an investigational treatment during the previous 3 months - Planned (date) elective surgery during the study period except for - cataract surgery - vascular access surgery - Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the maintenance of haemoglobin concentrations with once-monthly subcutaneous C.E.R.A. therapy in pre-dialysis patients with chronic renal anaemia previously treated with darbepoetin alfa .;Secondary Objective: To evaluate the safety and tolerability of once monthly subcutaneous C.E.R.A. in the treatment of anaemia in patients with chronic kidney disease. Exploratory objectives: -to assess the risk stratification cut-points of NT-proBNP for cardiovascular events in pre-dialysis patients under ESA treatment. -to assess the prediction potential of NT-proBNP for dialysis initiation. ;Primary end point(s): Primary efficacy endpoint: -The proportion of patients maintaining average haemoglobin concentration during the EEP within the target range. Secondary efficacy endpoints: -Change in haemoglobin concentration between baseline and the EEP -The proportion of patients maintaining average haemoglobin concentration during the EEP within the range 10.5 – 12.5 g/dL. -Mean time spent in the haemoglobin range 10.5 - 12.5 g/dL during the EEP. -Proportion of patients requiring any dose adjustment during the dose titration and evaluation periods Safety endpoints -Incidence of Adverse Events during the study -Changes and abnormalities in laboratory safety parameters -The incidence of red blood cell transfusions during the C.E.R.A. treatment phase -Reports of anti-epoetin antibodies Exploratory endpoints -to assess the risk stratification cut-points of NT-proBNP for cardiovascular events in pre-dialysis patients under ESA treatment -the prediction potential of NT-proBNP for dialysis initiation | — |
Countries
Sweden
Outcome results
None listed