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. MedDRA version: 9.1 Level: LLT Classification code 10058132 Term: Renal anemia
Conditions
Interventions
Trade Name: Mircera
Pharmaceutical Form: Solution for injection
INN or Proposed INN: polyethylene glycol-epoetin beta
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Conce
Sponsors
Roche (Hungary) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Age 18 years or older • Chronic renal anaemia. • Haemoglobin concentration between 10.0 g/dL and 12.0 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 mmHg despite medication. Average of 2 values measured at least two hours apart before dialysis. • Significant acute or chronic bleeding such as overt gastrointestinal bleeding • Active malignant disease (except non-melanoma skin cancer) • Haemolysis: haptoglobin 500 giga/L or <100 giga/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 at investigator’s discretion, during the previous 3 months • Uncontrolled or symptomatic secondary hyperparathyroidism, at investigator’s discretion • 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 • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication • Planned (date) elective surgery during the study period except for cataract surgery and 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: 1. To evaluate the safety and tolerability of C.E.R.A. once monthly in the treatment of anaemia in patients with chronic kidney disease. 2. To explore associations between NT-proBNP levels and clinical outcomes observed during the study. ;Primary end point(s): Primary efficacy endpoint: • The proportion of patients maintaining average haemoglobin concentration during the Efficacy Evaluation Period within the target range. | — |
Countries
Hungary
Outcome results
None listed