Trial Outcomes & Findings for A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis (NCT NCT00559273)
NCT ID: NCT00559273
Last Updated: 2016-11-01
Results Overview
Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
307 participants
Primary outcome timeframe
Baseline up to Week 28
Results posted on
2016-11-01
Participant Flow
Participant milestones
| Measure |
Mircera
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Correction Period (20 Weeks)
STARTED
|
153
|
154
|
|
Correction Period (20 Weeks)
Treated
|
151
|
154
|
|
Correction Period (20 Weeks)
COMPLETED
|
144
|
142
|
|
Correction Period (20 Weeks)
NOT COMPLETED
|
9
|
12
|
|
Evaluation Period (8 Weeks)
STARTED
|
144
|
142
|
|
Evaluation Period (8 Weeks)
COMPLETED
|
141
|
137
|
|
Evaluation Period (8 Weeks)
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Mircera
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Correction Period (20 Weeks)
Death
|
3
|
4
|
|
Correction Period (20 Weeks)
Adverse Event
|
2
|
1
|
|
Correction Period (20 Weeks)
Withdrawal by Subject
|
2
|
6
|
|
Correction Period (20 Weeks)
Participant treated by another center
|
0
|
1
|
|
Correction Period (20 Weeks)
Did not received study treatment
|
2
|
0
|
|
Evaluation Period (8 Weeks)
Death
|
1
|
3
|
|
Evaluation Period (8 Weeks)
Adverse Event
|
0
|
1
|
|
Evaluation Period (8 Weeks)
Withdrawal by Subject
|
2
|
0
|
|
Evaluation Period (8 Weeks)
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Baseline characteristics by cohort
| Measure |
Mircera
n=150 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=155 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 14.37 • n=93 Participants
|
67.4 years
STANDARD_DEVIATION 13.40 • n=4 Participants
|
66.3 years
STANDARD_DEVIATION 13.91 • n=27 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
172 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
133 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 28Population: Intent-to-treat (ITT) population included all randomized participants. Participants were analyzed according to the study treatment assigned.
Hb response was an observed increase in Hb greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without red blood cells (RBC) transfusion before response.
Outcome measures
| Measure |
Mircera
n=153 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Percentage of Participants With Hemoglobin (Hb) Response
|
94.12 percentage of participants
Interval 89.13 to 97.28
|
93.51 percentage of participants
Interval 88.38 to 96.84
|
PRIMARY outcome
Timeframe: Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)Population: ITT population. Here, N (number of participants analyzed)=participants evaluable for this measure. Missing data were imputed using last value carried forward.
A time adjusted average baseline Hb concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the 2 month evaluation period (Week 21 to 28). The change in Hb concentration between the baseline and evaluation period was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
Outcome measures
| Measure |
Mircera
n=150 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=151 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
|
1.66 g/dL
Standard Deviation 1.18
|
1.69 g/dL
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)Population: ITT population. Here, n=number of evaluable participants at specified time point, respectively for each group.
The hemoglobin concentration was measured in g/dL every 2 weeks and at final visit.
Outcome measures
| Measure |
Mircera
n=153 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Hemoglobin (Hb) Concentration Over the Time
Baseline (n=153, 154)
|
9.53 g/dL
Standard Deviation 0.74
|
9.53 g/dL
Standard Deviation 0.65
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 2 (n=149, 151)
|
10.22 g/dL
Standard Deviation 0.91
|
10.14 g/dL
Standard Deviation 0.93
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 10 (n=150, 146)
|
11.36 g/dL
Standard Deviation 1.27
|
11.78 g/dL
Standard Deviation 1.02
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 12 (n=149, 145)
|
11.24 g/dL
Standard Deviation 1.17
|
11.82 g/dL
Standard Deviation 1.03
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 26 (n=139, 136)
|
11.17 g/dL
Standard Deviation 0.96
|
11.24 g/dL
Standard Deviation 0.94
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 28 (n=139, 136)
|
11.08 g/dL
Standard Deviation 0.97
|
11.48 g/dL
Standard Deviation 0.91
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 4 (n=149, 148)
|
10.37 g/dL
Standard Deviation 1.17
|
10.74 g/dL
Standard Deviation 1.02
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 6 (n=149, 148)
|
10.94 g/dL
Standard Deviation 1.23
|
11.28 g/dL
Standard Deviation 1.08
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 8 (n=148, 147)
|
11.08 g/dL
Standard Deviation 1.29
|
11.74 g/dL
Standard Deviation 1.05
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 14 (n=145, 143)
|
11.53 g/dL
Standard Deviation 1.11
|
11.81 g/dL
Standard Deviation 1.04
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 16 (n=144, 145)
|
11.50 g/dL
Standard Deviation 1.16
|
11.76 g/dL
Standard Deviation 1.06
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 18 (n=144, 141)
|
11.41 g/dL
Standard Deviation 1.04
|
11.45 g/dL
Standard Deviation 0.94
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 20 (n=142, 140)
|
11.14 g/dL
Standard Deviation 0.92
|
11.34 g/dL
Standard Deviation 0.81
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 22 (n=142, 138)
|
11.39 g/dL
Standard Deviation 1.02
|
11.43 g/dL
Standard Deviation 0.86
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 24 (n=140, 140)
|
11.06 g/dL
Standard Deviation 0.98
|
11.26 g/dL
Standard Deviation 1.00
|
|
Hemoglobin (Hb) Concentration Over the Time
Week 29 (n=151, 151)
|
11.07 g/dL
Standard Deviation 1.10
|
11.31 g/dL
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline up to Week 28Population: ITT population.
Time to Hb response is defined as the number of study days until the first occurrence of an Hb response. Participants without events were censored at the time of evaluation. Median and 95 percent (%) confidence interval (CI) were estimated using Kaplan-Meier Survival Analysis. Hb response was an observed increase in Hb \>=1.0 g/dL from baseline and an Hb concentration \>= 10.0 g/dL before the end of the study without RBC transfusion before response.
Outcome measures
| Measure |
Mircera
n=153 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Time to Hemoglobin Response
|
43 days
Interval 37.0 to 43.0
|
29 days
Interval 29.0 to 41.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 28Population: ITT population.
The percentage of participants who received RBC transfusions during the titration and evaluation periods were reported.
Outcome measures
| Measure |
Mircera
n=153 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Percentage of Participants With Red Blood Cell (RBC) Transfusions
|
3.3 percentage of participants
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: ITT population. Here, N=number of participants evaluable for this measure.
Percentage of participants having at least one Hb value greater than (\>) 12 g/dL during the first 8 weeks of the study was reported.
Outcome measures
| Measure |
Mircera
n=151 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=151 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL
|
25.8 percentage of participants
|
47.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: ITT population.
A participant was defined as having achieved a stable Hb response, if at least 75 percent (%) of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and \>=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were \>=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2). There were at least 3 recorded Hb values within the time window.
Outcome measures
| Measure |
Mircera
n=153 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=154 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Percentage of Participants With Stable Hemoglobin Response
|
68.63 percentage of participants
Interval 60.64 to 75.88
|
72.73 percentage of participants
Interval 64.97 to 79.58
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: ITT population. Here, N=number of participants analyzed for this measure.
The total number of dose adjustments needed to achieve stabilized response was calculated from Day 1 until the first 8-week time window in which response was achieved. A participant was defined as having achieved a stable Hb response, if at least 75% of the scheduled Hb values were between 10.0 g/dL and 12.0 g/dL and \>=1.0 g/dL from baseline for any 8-week time period, regardless of the requirement for dose adjustment for Hb maintenance. Achievement of stable response was determined using a moving 8-week time window, moving forward by 14 days in each iteration starting at Day 15, searching to see if the following conditions were met: 1) At least 3 scheduled Hb values (75% of the scheduled Hb values) in any 8-week time window were \>=1.0 g/dL from baseline (as calculated above) and within the range of 10.0 g/dL to 12.0 g/dL. 2) There were at least 3 recorded Hb values within the time window.
Outcome measures
| Measure |
Mircera
n=105 Participants
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=112 Participants
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
Dose Decrease(s) only
|
8.6 percentage of participants
|
19.6 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
No Dose Change
|
38.1 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
Dose Increase(s) only
|
41.9 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
Dose Decrease(s) and Increase(s)
|
11.4 percentage of participants
|
18.8 percentage of participants
|
Adverse Events
Mircera
Serious events: 28 serious events
Other events: 50 other events
Deaths: 0 deaths
Darbepoetin Alfa
Serious events: 39 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mircera
n=150 participants at risk
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=155 participants at risk
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Renal and urinary disorders
Renal impairment
|
2.7%
4/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
5.8%
9/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Renal and urinary disorders
Renal failure acute
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Bradycardia
|
1.3%
2/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
2/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.3%
2/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Cardiac failure
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Cardiogenic shock
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
3.2%
5/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Urinary tract infection
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
1.3%
2/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Sepsis
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Diabetic gangrene
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Osteomyelitis
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Septic shock
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
2/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
1.3%
2/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Metabolism and nutrition disorders
Starvation
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
1.3%
2/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia recurrent
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma metatstatic
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Nervous system disorders
Dementia
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Vascular disorders
Hypertension
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
General disorders
Sudden death
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Hepatobiliary disorders
Jaundice
|
0.67%
1/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.00%
0/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
0.65%
1/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
Other adverse events
| Measure |
Mircera
n=150 participants at risk
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
|
Darbepoetin Alfa
n=155 participants at risk
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
16.0%
24/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
23.9%
37/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Vascular disorders
Hypotension
|
3.3%
5/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
5.2%
8/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
9/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
7.1%
11/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
5/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
5.2%
8/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
5/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
7.7%
12/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
10/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
3.9%
6/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
12/150 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
4.5%
7/155 • Baseline up to 29 weeks
Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.
|
Additional Information
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