Chronic renal anemia. MedDRA version: 9.1 Level: LLT Classification code 10039812 Term: Secondary 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: RO0503821
Concentration uni
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 1.0 at screening for haemodialysis patients (or URR >55%) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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 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 - 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 haemodialysis 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