A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
Anemia

About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria: Written informed consent Adult patients (≥ 18 years old) with chronic renal anemia Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484] Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10% Exclusion Criteria: Poorly controlled hypertension History of epileptic seizure Pure red cell aplasia Chronic congestive heart failure [New York Heart Association (NYHA) IV] High likelihood of early withdrawal or interruption of the study Active malignant disease (except non-melanoma skin cancer) Life expectancy less than 12 months Pregnancy or breast-feeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Methoxy Polyethylene Glycol-Epoetin Beta
Comparator ESA
Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.