Chronic renal anaemia MedDRA version: 9.1 Level: LLT Classification code 10058123 Term: Renal anaemia
Conditions
Interventions
Product Name: C.E.R.A.
Product Code: RO0503821
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: RO0503821
Other descriptive name: CERA
Concentration unit: µg microgram(s)
Concentration
Sponsors
Roche s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age 18 years and older 3. Chronic renal anaemia 4. Haemoglobin concentration between 10.5g/dl and 12.5g/dl 5. Adequite iron status (serum ferritin > 100ng/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: 1. Transfusion of red blood cells during the previous 2 months 2. Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 despite medication requiring hospitalization or interruption of epoetin (epoetin alfa, epoetin beta or darbopoetin alfa) treatment in the previous 6 months 3. Significant acute or chronic bleeding such as overt gastrointestinal bleeding 4. Active malignant disease (except non-melanoma skin cancer) 5. Haemolysis 6. Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) 7. Folic acid deficiency 8. Vitamin B12 deficiency 9. Platelet count > 500 x10 9/l or < 100x 10 9/l 10. Pure red cell aplasia 11. Epileptic seizure during previous 6 months 12. Congestive heart failure (NYHA Class IV) 13. Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months 14. Uncontrolled or symptomatic secondary hyperparathyroidism 15. Pregnancy or lactation period 16. Women of childbearing potential without effective contraception 17. Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous 3 months 18. Known hypersensitivity to recobinant human erathropoietin, polyethylene glycol or to any constituent of the study medication 19. 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 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 avetrage haemoglobin concentration during the EEP within the target range. | — |
Countries
Czech Republic
Outcome results
None listed