Chronic renal anemia MedDRA version: 9.1 Level: LLT Classification code 10058124 Term: Nephrogenic anemia
Conditions
Interventions
Product Name: C.E.R.A.
Product Code: Ro050 3821
Pharmaceutical Form: Solution for injection
Current Sponsor code: RO0503821/F25
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: eq
Sponsors
Roche a/s
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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 call 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 • Temporary (untunneled) dialysis access catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the maintenance of haemoglobin concentrations with once-monthly intravenous C.E.R.A. therapy in haemodialysis patients with chronic renal anaemia previously treated with darbepoetin alfa or epoetin alfa;Secondary Objective: to evaluate the safety and tolerability of once monthly intravenous C.E.R.A. in the treatment of anaemia in patients with chronic kidney disease;Primary end point(s): Primary Efficacy Endpoint •The proportion of patients maintaining average haemoglobin concentration during the EEP within the target range | — |
Countries
Denmark
Outcome results
None listed