Chronic renal anemia MedDRA version: 8.1 Level: PT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Interventions
Product Name: C.E.R.A
Product Code: RO0503821
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not Available
CAS Number: 677324-53-7
Current Sponsor code: RO0503821
Concentration unit:
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Adult patients (= 18 years old) with chronic renal anemia 3. Regular long-term hemodialysis three times weekly for at least 12 weeks before screening and during the screening/baseline period 4. Kt/V = 1.2 or URR = 65% 5. Baseline hemoglobin concentration between 11.0 and 13.0 g/dL (mean of the weekly hemoglobin values determined in weeks -4 to -1) 6. Stable baseline hemoglobin concentration (defined as an absolute difference less than or equal to 1 g/dL between the mean hemoglobin values determined in weeks -4 and -3 and the mean hemoglobin values determined in weeks -2 and -1) 7. Continuous intravenous once-weekly maintenance darbepoetin therapy for at least 8 weeks before screening and during the screening/baseline period 8. Stable intravenous once-weekly maintenance darbepoetin therapy during the screening/baseline period (a maximum of one dose change according to approved labeling) 9. Adequate iron status defined as serum ferritin = 100 ng/mL or TSAT = 20% (or percentage of hypochromic RBCs =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of treatment with any ESA at a dosing interval longer than once-weekly since the start of dialysis treatment 2. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening/baseline period 3. RBC transfusions within 8 weeks before screening or during the screening/baseline period 4. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) 5. Hemolysis 6. Active malignancy (except non-melanoma skin cancer). Patients with malignant disease who have been disease-free for at least the 5 previous years are eligible 7. Chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) 8. Acute infection 9. CRP > 30 mg/L 10. Temporary (untunneled) dialysis access catheter 11. Vitamin B12 deficiency 12. Folic acid deficiency 13. Uncontrolled or symptomatic secondary hyperparathyroidism 14. Poorly controlled hypertension necessitating interruption of treatment with erythropoiesis stimulating agents in the 3 months before screening or during the screening/baseline period 15. Epileptic seizure in the 6 months before screening or during the screening/baseline period 16. Platelets > 500 x 10 exp9/L 17. Pure red cell aplasia 18. Chronic congestive heart failure (New York Heart Association Class IV) 19. High likelihood of early withdrawal or interruption of the study (e.g. myocardial infarction, severe or unstable coronary artery disease, stroke or severe liver disease within the 12 weeks before screening or during the screening/baseline period) 20. Planned elective surgery during the study period (patients who undergo vascular access surgery, cataract surgery or laser photocoagulation may continue to participate) 21. Life expectancy less than 12 months 22. Pregnancy or breast-feeding 23. Women of childbearing potential without effective contraception 24. Administration of another investigational drug within 4 weeks before screening or planned during the study period 25. Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations 26. Previous treatment with RO0503821
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: - To compare the efficacy of RO0503821 administered intravenously at extended dosing intervals with that of darbepoetin alfa in the maintenance of hemoglobin concentrations in hemodialysis patients on intravenous darbepoetin alfa maintenance treatment of chronic renal anemia ;Secondary Objective: Secondary: - To assess the safety and tolerability of intravenous administration of RO0503821 in hemodialysis patients on intravenous darbepoetin alfa maintenance treatment of chronic renal anemia ;Primary end point(s): - The proportion of all randomized patients with an average Hb decrease from baseline not exceeding 1.0 g/dL and an average Hb = 10.5 g/dL in weeks 50-53 | — |
Countries
Austria, Finland, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed