Chronic renal anaemia MedDRA version: 9.1 Level: LLT Classification code 10058123 Term: Renal anaemia
Conditions
Interventions
Trade Name: Mircera
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methoxy polyethylene glycol-epoetin beta
CAS Number: 677324-53-7
Current Sponsor code: Ro 0503821
Concentration un
Sponsors
ROCHE
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 despite medication requiring hospitalization or interruption of darbopoetin 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 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 vascular access surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long term maintenance of haemoglobin levels, with once-monthly subcutaneous administration of C.E.R.A. in pre-dialysis patients with chronic renal anaemia.;Secondary Objective: To evaluate the safety and tolerability of C.E.R.A. once monthly in the treatment of anaemia in patients with chronic kidney disease;Primary end point(s): The proportion of patients maintaining average haemoglobin concentration during the EEP within the target range | — |
Countries
Italy
Outcome results
None listed