This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc 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
572
iv 3 times weekly, as prescribed
60, 100 or 180 micrograms sc (starting dose) every 2 weeks
60, 100 or 180 micrograms sc (starting dose) every 4 weeks
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
A time adjusted mean change in hemoglobin (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 value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
Time frame: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.
Time frame: Evaluation period (Week 29 to Week 36)
Number of Participants With Red Blood Cell Transfusions
The number of participants who received RBC transfusions were reported.
Time frame: Up to Week 36
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Unnamed facility
Hot Springs, Arkansas, United States
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Los Angeles, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Jose, California, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Brooklyn Center, Minnesota, United States
Unnamed facility
Raleigh, North Carolina, United States
...and 80 more locations
Time frame: Up to week 52
Number of Participants With Marked Laboratory Abnormalities
A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10\^9/L), platelets (100 - 550 10\^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter \[U/L\]), alkaline phosphatase (ALP \[0 - 220 U/L\]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin \>= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter \[mmol/L\]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
Time frame: Up to week 52
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52