Chronic renal anaemia MedDRA version: 9.1 Level: PT Classification code 10058116 Term:
Conditions
Interventions
Trade Name: MIRCERA
Product Name: C.E.R.A. (Ro 050-3821)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
Current Sponsor code: Ro 050-3821/F03
Sponsors
N.V. Roche S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent •Age 18 years or older •Chronic renal anaemia defined as a GFR 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 in the previous 6 months •Significant acute or chronic bleeding such as overt gastrointestinal bleeding •Active malignant disease (except non-melanoma skin cancer) •History of primary bone marrow diseases •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 the 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 •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 •History of organ transplantation •Life expectancy < 8 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess effectiveness of monthly subcutaneous administration of C.E.R.A. to correct and /or maintain haemoglobin levels in patients with chronic renal anaemia not on dialysis and not currently treated with ESA.;Secondary Objective: Secondary objectives: - To evaluate the safety and tolerability of C.E.R.A. monthly dosing in the treatment of anaemia and then monthly for maintenance in patients with chronic kidney disease. Exploratory objectives: - To explore associations between NT-proBNP levels and clinical outcomes observed during the study. - To explore associations between metabolic acidosis, serum lactate levels, IL-6 levels and C.E.R.A. dose requirements. ;Primary end point(s): Key outcomes will be assessed during the first 8 weeks following the 28 week dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Primary efficacy endpoint - The proportion of patients maintening average haemoglobin concentration during EEP within the target range | — |
Countries
Belgium
Outcome results
None listed