A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period

The Baseline (Safety Verification Period) was from Week - 4 to Week -1.

Time frame: Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)

Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period

Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.

Time frame: EEP (Weeks 29 to 36)

Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period

Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.

Time frame: EEP (Week 29 to Week 36)

Number of Participants Who Required Dose Adjustments During the Dose Titration Period

The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.

Time frame: DTP (Weeks 0 to 28)

Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period

The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.

Time frame: EEP (Weeks 29 to 36)

Number of Participants Received Red Blood Cells Transfusions

The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.

Time frame: Up to Week 28

Mean Values of Hemoglobin Concentration at Baseline and Week 36

The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Hematocrit at Baseline and Week 36

Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Mean Corpuscular Volume at Baseline and Week 36

Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Leukocytes and Platelets Count at Baseline and Week 36

The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36

Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.

Time frame: Baseline and Week 36

Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36

The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Ferritin Concentration at Baseline and Week 36

Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Transferrin Saturation at Baseline and Week 36

The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36

The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.

Time frame: Baseline and Week 36

Number of Participants With Adverse Events and Serious Adverse Events

An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.

Time frame: Up to Week 40

Number of Participants With Abnormal Changes in ECG From Baseline to Week 40

Twelve-lead ECG was performed.

Time frame: From Baseline to Week 40

Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40

Vital signs included blood pressure, pulse rate and body weight.

Time frame: From Baseline to Week 40