This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
673
intravenously 3 times weekly for 52 weeks, as prescribed
60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.
Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period
A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
Time frame: Baseline, Week 29 to Week 36
Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.
Time frame: Baseline, Week 29 to Week 36
The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
The number of participants who received RBC transfusions during the titration and evaluation periods were reported .
Time frame: Week 1 to Week 36
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10\^9/Litre \[L\], for WBC was 3.0-18.0.0x10\^9/L, and for RBC was 3.80-6.10x10\^12/L.
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Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Montgomery, Alabama, United States
Unnamed facility
Encino, California, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Monterey Park, California, United States
Unnamed facility
Riverside, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
...and 89 more locations
Time frame: Up to Week 53
Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre \[U/L\]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin \>=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre \[mmol/L\]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L
Time frame: Up to Week 53
Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).
Time frame: Baseline, Week 36 and Week 52
Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52
Change in pulse rate (beats per minute \[bpm\]) from baseline values includes only those participants with both a baseline value and a value for specified time period.
Time frame: Baseline, Week 36 and Week 52
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.
Time frame: Upto Week 53