The primary purpose of this study is to demonstrate that RO0503821 administered intravenously maintains hemoglobin concentrations in dialysis patients on prior intravenous darbepoetin alfa maintenance treatment of chronic renal anemia. The secondary purpose is to assess the safety and tolerability of intravenous administration of RO0503821 in this patient population.
– Renal Anemia
Treatment, randomized, controlled, open-label, multi-centre, parallel group study.
Eligibility & Criteria
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria:Written informed consent Adult patients (greater than or equal to 18 years old) with chronic renal anemia Regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 12 weeks before screening and during the screening/baseline period Urea clearance/volume (Kt/V) greater than or equal to 1.2 or percent reduction of urea (URR) greater than or equal to 65% for hemodialysis patients or weekly urea clearance/volume (Kt/V) greater than or equal to 1.8 for peritoneal dialysis patients Baseline hemoglobin concentration between 10.5 and 13 g/dL (mean of the weekly hemoglobin values determined in weeks -4 to -1) 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) Continuous intravenous maintenance darbepoetin alfa therapy with the same dosing interval (i.e., once a week or once every two weeks) for at least 8 weeks before screening and during the screening/baseline period Stable intravenous maintenance darbepoetin alfa therapy during the screening/baseline period (a maximum of one weekly dose change is allowed: this change should not exceed 25% compared to the weekly dose administered in the week preceding screening) Adequate iron status defined as serum ferritin greater than or equal to 100 ng/mL or transferrin saturation (TSAT) greater than or equal to 20% (or percentage of hypochromic RBCs less than 10%) (mean of two values determined in weeks -4 and -3) Exclusion Criteria:Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 weeks before screening or during the screening/baseline period RBC transfusions within 8 weeks before screening or during the screening/baseline period Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) Hemolysis Active malignant disease (except non-melanoma skin cancer) Chronic, uncontrolled or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) Acute infection CRP (C Reactive Protein) greater than 30 mg/L Temporary (untunneled) dialysis access catheter Vitamin B12 deficiency Folic acid deficiency Uncontrolled or symptomatic secondary hyperparathyroidism Poorly controlled hypertension necessitating interruption of epoetin or darbepoetin alfa treatment in the 6 months before screening – Epileptic seizure in the 6 months before screening Platelets greater than 500 x 10 9/L Pure red cell aplasia Chronic congestive heart failure (New York Heart Association Class IV) 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 or during the screening/baseline period) Planned elective surgery during the study period Life expectancy less than 12 months Pregnancy or breast-feeding Women of childbearing potential without effective contraception Previous treatment with RO0503821 Administration of another investigational drug within 4 weeks before screening or planned during the study period Known hypersensitivity to darbepoetin alfa, recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations
 Hoffmann-La Roche BLACKTOWN, NSW 2148, Australia