This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
0.6 micrograms/kg every 2 weeks
As prescribed, iv, 3 times weekly
Unnamed facility
Gyeonggi-do, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb\>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented
Time frame: Up to Week 24
Mean Change From Baseline in Hemoglobin Concentration at Week 24
Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value
Time frame: From Baseline (Day 1) to Week 24
Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24
Median time during the correction period in which Hb value was maintained within target range of \>/= 11.0 g/dL and an increase in hemoglobin from baseline \>/= 1.0 g/dL was reported.
Time frame: Up to Week 24
Number of Participants Who Received Red Blood Cells Transfusions up to Week 49
The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)
Time frame: Up to Week 49
Number of Participants With Any 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.
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Seoul, South Korea
Unnamed facility
Seoul, South Korea
Unnamed facility
Sungnam, South Korea
Time frame: Up to Week 49
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Time frame: From Baseline (Day 1) to Week 24
Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24
Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Time frame: From Baseline (Day 1) to Week 24
Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24
Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Time frame: Up to Week 24