Trial Outcomes & Findings for A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. (NCT NCT00560404)
NCT ID: NCT00560404
Last Updated: 2025-09-11
Results Overview
The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter \[g/dL\]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
EEP (Week 29 to Week 36)
Results posted on
2025-09-11
Participant Flow
A total of 457 participants were enrolled across 24 centers in Brazil from period April 02, 2008 to July 02, 2009.
All participants received epoetin alpha during a four-week safety verification period. Of 457 participants, 233 eligible participants entered the treatment period.
Participant milestones
| Measure |
C.E.R.A.
Participants received RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A.\]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
121
|
|
Overall Study
COMPLETED
|
76
|
100
|
|
Overall Study
NOT COMPLETED
|
36
|
21
|
Reasons for withdrawal
| Measure |
C.E.R.A.
Participants received RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A.\]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Protocol Violation
|
12
|
7
|
|
Overall Study
Administrative Reasons
|
1
|
1
|
|
Overall Study
Withdrew Consent
|
4
|
0
|
|
Overall Study
Failure to return
|
1
|
2
|
|
Overall Study
Other withdrawal reason
|
13
|
5
|
Baseline Characteristics
A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Baseline characteristics by cohort
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
53.0 years
n=7 Participants
|
54.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: EEP (Week 29 to Week 36)Population: Per-protocol population included participants who received at least one dose of C.E.R.A. and had data of at least one follow-up variable excluding those participants who had not adhere the inclusion/exclusion criteria, had less than 3 recorded Hb values, and received any other epoetin alpha and blood transfusion in Weeks 0 to 44.
The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter \[g/dL\]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.
Outcome measures
| Measure |
C.E.R.A.
n=76 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=100 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
|
50.7 percentage of participants
|
53.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)Population: The analysis was performed on ITT population.
The Baseline (Safety Verification Period) was from Week - 4 to Week -1.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period
|
-0.02 g/dL
Standard Deviation 1.40
|
0.05 g/dL
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: EEP (Weeks 29 to 36)Population: The analysis was performed on ITT population.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period
|
30.9 percentage of participants
|
39.4 percentage of participants
|
SECONDARY outcome
Timeframe: EEP (Week 29 to Week 36)Population: The analysis was performed on ITT population.
Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period
|
30.4 days
Standard Deviation 19.5
|
33.9 days
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: DTP (Weeks 0 to 28)Population: The analysis was performed on ITT population.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Number of Participants Who Required Dose Adjustments During the Dose Titration Period
|
88 participants
|
98 participants
|
SECONDARY outcome
Timeframe: EEP (Weeks 29 to 36)Population: The analysis was performed on ITT population.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period
|
35 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Up to Week 28Population: The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Number of Participants Received Red Blood Cells Transfusions
|
8 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Hemoglobin Concentration at Baseline and Week 36
Baseline, n = 112, 121
|
11.6 g/dL
Standard Deviation 0.54
|
11.6 g/dL
Standard Deviation 0.57
|
|
Mean Values of Hemoglobin Concentration at Baseline and Week 36
Week 36; n = 75, 98
|
11.5 g/dL
Standard Deviation 1.33
|
11.7 g/dL
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Hematocrit at Baseline and Week 36
Hematocrit, Baseline, n = 112, 121
|
0.35 fraction
Standard Deviation 0.02
|
0.35 fraction
Standard Deviation 0.02
|
|
Mean Values of Hematocrit at Baseline and Week 36
Hematocrit, Week 36, n = 75, 98
|
0.35 fraction
Standard Deviation 0.04
|
0.36 fraction
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Mean Corpuscular Volume at Baseline and Week 36
Baseline; n = 112, 121
|
91.9 femtoliters
Standard Deviation 5.95
|
92.2 femtoliters
Standard Deviation 5.26
|
|
Mean Values of Mean Corpuscular Volume at Baseline and Week 36
Week 36; n = 74, 97
|
90.6 femtoliters
Standard Deviation 6.79
|
91.6 femtoliters
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
Leukocytes, Baseline, n = 112, 121
|
6.8 10^9/Litre
Standard Deviation 1.96
|
6.6 10^9/Litre
Standard Deviation 1.97
|
|
Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
Leukocytes, Week 36, n = 75, 98
|
6.5 10^9/Litre
Standard Deviation 1.81
|
6.5 10^9/Litre
Standard Deviation 1.90
|
|
Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
Platelets counts, Baseline, n = 112, 121
|
194.8 10^9/Litre
Standard Deviation 48.79
|
204.4 10^9/Litre
Standard Deviation 58.46
|
|
Mean Values of Leukocytes and Platelets Count at Baseline and Week 36
Platelets counts, Week 36, n = 75, 98
|
193.3 10^9/Litre
Standard Deviation 55.11
|
210.6 10^9/Litre
Standard Deviation 73.28
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Creatinine, Baseline, n = 109, 116
|
850.4 micromoles per liter
Standard Deviation 242.22
|
916.6 micromoles per liter
Standard Deviation 636.75
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Creatinine, Week 36, n = 72, 95
|
881.0 micromoles per liter
Standard Deviation 281.60
|
876.1 micromoles per liter
Standard Deviation 265.33
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Potassium, Baseline, n = 112, 121
|
5.2 micromoles per liter
Standard Deviation 0.90
|
5.2 micromoles per liter
Standard Deviation 0.83
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Potassium, Week 36, n = 75, 99
|
5.0 micromoles per liter
Standard Deviation 0.74
|
5.0 micromoles per liter
Standard Deviation 0.82
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
TIBC, Baseline, n = 60, 59
|
37.0 micromoles per liter
Standard Deviation 14.6
|
38.6 micromoles per liter
Standard Deviation 10.23
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
TIBC, Week 36, n = 31, 43
|
39.5 micromoles per liter
Standard Deviation 15.4
|
39.4 micromoles per liter
Standard Deviation 11.28
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Iron, Baseline, n = 112, 121
|
14.2 micromoles per liter
Standard Deviation 5.98
|
14.5 micromoles per liter
Standard Deviation 6.12
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
Iron, Week 36, n = 73, 97
|
17.5 micromoles per liter
Standard Deviation 7.94
|
12.5 micromoles per liter
Standard Deviation 5.73
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
PTH, Baseline, n = 111, 121
|
228.3 micromoles per liter
Standard Deviation 145.33
|
217.9 micromoles per liter
Standard Deviation 158.57
|
|
Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36
PTH, Week 36, n = 18, 24
|
313.4 micromoles per liter
Standard Deviation 297.39
|
368.2 micromoles per liter
Standard Deviation 279.66
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=111 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=118 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
Albumin, Baseline, n = 111, 118
|
39.2 gram/litre
Standard Deviation 4.14
|
39.9 gram/litre
Standard Deviation 4.71
|
|
Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
Albumin, Week 36, n = 72, 92
|
39.3 gram/litre
Standard Deviation 3.89
|
39.8 gram/litre
Standard Deviation 4.57
|
|
Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
Transferrin, Baseline, n = 56, 66
|
1.65 gram/litre
Standard Deviation 0.38
|
1.77 gram/litre
Standard Deviation 0.36
|
|
Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36
Transferrin, Week 36, n = 39, 49
|
1.76 gram/litre
Standard Deviation 0.39
|
1.67 gram/litre
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Ferritin Concentration at Baseline and Week 36
Ferritin, Baseline, n = 112,121
|
777.8 micrograms per liter
Standard Deviation 529.23
|
621.4 micrograms per liter
Standard Deviation 415.90
|
|
Mean Values of Ferritin Concentration at Baseline and Week 36
Ferritin, Week 36, n = 72, 93
|
736.9 micrograms per liter
Standard Deviation 467.00
|
609.9 micrograms per liter
Standard Deviation 379.53
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Transferrin Saturation at Baseline and Week 36
TS, Baseline; n = 112, 121
|
38.0 percentage
Standard Deviation 17.32
|
36.2 percentage
Standard Deviation 17.96
|
|
Mean Values of Transferrin Saturation at Baseline and Week 36
TS, Week 36; n = 70, 91
|
44.4 percentage
Standard Deviation 23.64
|
31.7 percentage
Standard Deviation 18.72
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: The analysis was performed on safety population. The "n" represents the number of participants analyzed at a specified time point..
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.
Outcome measures
| Measure |
C.E.R.A.
n=109 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=119 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
AST, Baseline, n = 109, 117
|
16.4 International units/Liter
Standard Deviation 7.48
|
16.6 International units/Liter
Standard Deviation 8.09
|
|
Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
AST, Week 36, n = 74, 96
|
17.2 International units/Liter
Standard Deviation 10.07
|
17.1 International units/Liter
Standard Deviation 12.47
|
|
Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
ALP, Baseline, n = 108, 119
|
106.4 International units/Liter
Standard Deviation 51.01
|
118.0 International units/Liter
Standard Deviation 73.44
|
|
Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36
ALP, Week 36, n = 73, 93
|
116.2 International units/Liter
Standard Deviation 77.4
|
129.7 International units/Liter
Standard Deviation 84.99
|
SECONDARY outcome
Timeframe: Up to Week 40Population: The analysis was performed on Safety Population.
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.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any AE
|
99 participants
|
106 participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Any SAE
|
27 participants
|
16 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 40Population: The analysis was performed on Safety population.
Twelve-lead ECG was performed.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Changes in ECG From Baseline to Week 40
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 40Population: The analysis was performed on safety population.
Vital signs included blood pressure, pulse rate and body weight.
Outcome measures
| Measure |
C.E.R.A.
n=112 Participants
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 Participants
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40
|
0 participants
|
0 participants
|
Adverse Events
C.E.R.A.
Serious events: 27 serious events
Other events: 83 other events
Deaths: 0 deaths
Epoetin Alpha
Serious events: 16 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
C.E.R.A.
n=112 participants at risk
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 participants at risk
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Angina Unstable
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Cardiac disorders
Myocardial Infarction
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.8%
2/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
General disorders
Chest pain
|
1.8%
2/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
General disorders
Sudden death
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Hepatobiliary disorders
Cholestasis
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Appendicitis
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Endocarditis
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Infection
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Lung Infection
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Pneumonia
|
3.6%
4/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
3.3%
4/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypertensive Crisis
|
1.8%
2/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Urinary Tract Infection
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Aneurysm
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
1.8%
2/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypotension
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Renal Haematoma
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Investigations
Haemoglobin Decreased
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Varicose vein
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Localised Infection
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.00%
0/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Convulsion
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
0.83%
1/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
Other adverse events
| Measure |
C.E.R.A.
n=112 participants at risk
Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
|
Epoetin Alpha
n=121 participants at risk
Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
|
|---|---|---|
|
General disorders
Chest pain
|
7.1%
8/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.8%
7/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypotension
|
17.0%
19/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
16.5%
20/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.8%
11/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
10.7%
13/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
5/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
7.4%
9/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
14/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
7.4%
9/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.8%
7/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Gastritis
|
5.4%
6/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
4.1%
5/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
8/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.0%
6/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
8/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
1.7%
2/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
General disorders
Malaise
|
8.0%
9/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
3.3%
4/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Influenza
|
0.89%
1/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
8.3%
10/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Respiratory Tract Infection
|
5.4%
6/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
4.1%
5/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.5%
5/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
6.6%
8/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Infections and infestations
Urinary Tract Infection
|
4.5%
5/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.8%
7/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
5.4%
6/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
4.1%
5/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
5.4%
6/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
4.1%
5/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.7%
3/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.8%
7/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
6.2%
7/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
1.7%
2/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.5%
5/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.8%
7/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
9/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
13.2%
16/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
20.5%
23/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
14.0%
17/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.1%
8/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
9.1%
11/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Dizziness
|
5.4%
6/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.0%
6/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Nervous system disorders
Headache
|
10.7%
12/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
19.8%
24/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
9/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
1.7%
2/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
8/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
5.0%
6/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
|
Vascular disorders
Hypertension
|
16.1%
18/112 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
12.4%
15/121 • Up to Week 40 (follow up)
The adverse events were reported in safety analysis population. The safety analysis population included those participants who have been treated with at least one dose of the trial medication and a safety follow-up, whether withdrawn prematurely or not.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER