Patient with chronic renal anaemia
Conditions
Interventions
Product Name: N/A
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not available yet
Other descriptive name: Methoxy polyethylene glycol-epoetin beta
Concentrat
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 1. Written informed consent 2. Adult patients (equal or more than 18 years old) with chronic renal anemia 3. Continuous maintenance erythropoietic therapy with RO0503821 or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528, BA16285, BA16286, BA16736, BA16738, BA16739, BA16740, BA17283 and BA17284 4. Hemoglobin concentration between 10.5 and 13.0 g/dL 5. Adequate iron status defined as serum ferritin equal or more than 100 ng/mL or TSAT equal or more than 20% (or percentage of hypochromic RBCs =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 6. Poorly controlled hypertension necessitating interruption of erythropoietin treatment in the 6 months before screening 7. Epileptic seizure in the 6 months before screening 8. Platelets > 500 x 10 9/L 9. Pure red cell aplasia 10. Chronic congestive heart failure (New York Heart Association Class IV) 11. High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening) 12. Active malignant disease (except non-melanoma skin cancer) 13. Life expectancy less than 12 months 14. Pregnancy or breast-feeding 15. Women of childbearing potential without effective contraception 16. Administration of another investigational drug planned during the study period 17. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document that RO0503821 administered for prolonged periods is efficacious, safe and well tolerated in patients treated for chronic renal anemia;Secondary Objective: N/A;Primary end point(s): Analysis of Efficacy No formal efficacy assessment will be performed. Efficacy parameters such as hemoglobin will be reported descriptively using means, standard deviations and percentiles. Analysis of Safety All patients who have received at least one dose of RO0503821 or of reference medication and a safety follow-up, whether withdrawn prematurely or not, will be included in the safety analysis. The safety parameters will be vital signs, AEs and the safety laboratory parameters. All safety parameters will be summarized descriptively. Vital signs and laboratory data will be assessed for clinically relevant abnormalities. Frequencies and incidence rates of AEs will be tabulated. The goal of the statistical evaluation of AE data is a standardized tabulation of the frequencies and incidence rates of all observed AEs. These will be calculated on a per-patient basis rather than on an event basis. Brief narratives will describe each death, each drug related SAE, premature withdrawals arising from AEs, and other significant AEs that are judged to be of special interest because of clinical importance. All safety parameters will be summarized descriptively. Vital signs and laboratory data will be assessed for clinically relevant abnormalities. | — |
Countries
Austria, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed