Trial Outcomes & Findings for Observational Study of MIRCERA in Users of Self-Application and Multidose Systems (NCT NCT02540213)
NCT ID: NCT02540213
Last Updated: 2015-12-22
Results Overview
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.
Recruitment status
COMPLETED
Target enrollment
240 participants
Primary outcome timeframe
Baseline
Results posted on
2015-12-22
Participant Flow
Participant milestones
| Measure |
MIRCERA
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
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|---|---|
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Overall Study
STARTED
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240
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Overall Study
COMPLETED
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201
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Overall Study
NOT COMPLETED
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39
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Reasons for withdrawal
| Measure |
MIRCERA
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
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|---|---|
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Overall Study
Death/adverse event
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18
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Overall Study
Administrative reasons
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3
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Overall Study
Kidney transplant
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3
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Overall Study
Lack of Efficacy
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6
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Overall Study
Consent withdrawn
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7
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Overall Study
Enrolled but not treated
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2
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Baseline Characteristics
Observational Study of MIRCERA in Users of Self-Application and Multidose Systems
Baseline characteristics by cohort
| Measure |
MIRCERA
n=238 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Age, Continuous
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66.8 years
n=5 Participants
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Sex: Female, Male
Female
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109 Participants
n=5 Participants
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Sex: Female, Male
Male
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129 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.
Outcome measures
| Measure |
MIRCERA
n=221 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment
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83.7 percentage of participants
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PRIMARY outcome
Timeframe: Month 1Population: Participant Satisfaction Set.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=221 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Treatment
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93.7 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Application
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93.7 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Preparation
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95.9 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Storage
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96.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
Disposal
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92.3 percentage of participants
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PRIMARY outcome
Timeframe: Month 2Population: Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Treatment
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93.6 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Application
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92.7 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Preparation
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96.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Storage
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96.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
Disposal
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92.2 percentage of participants
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PRIMARY outcome
Timeframe: Month 3Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Treatment
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93.9 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Application
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91.5 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Preparation
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94.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Storage
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94.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
Disposal
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89.7 percentage of participants
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PRIMARY outcome
Timeframe: Month 4Population: Participant Satisfaction Set. Here N = participants who were available for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Treatment
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93.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Application
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91.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Preparation
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94.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Storage
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94.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
Disposal
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90.0 percentage of participants
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PRIMARY outcome
Timeframe: Month 5Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Treatment
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93.6 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Application
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92.2 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Preparation
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96.1 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Storage
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95.1 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
Disposal
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91.2 percentage of participants
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PRIMARY outcome
Timeframe: Month 6Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Treatment
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93.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Application
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92.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Preparation
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95.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Storage
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95.4 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
Disposal
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90.4 percentage of participants
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PRIMARY outcome
Timeframe: Month 7Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Treatment
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94.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Application
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92.7 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Preparation
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94.3 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Storage
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94.8 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
Disposal
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89.1 percentage of participants
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PRIMARY outcome
Timeframe: Month 8Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Treatment
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95.2 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Application
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94.1 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Preparation
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94.1 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Storage
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94.7 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
Disposal
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89.3 percentage of participants
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PRIMARY outcome
Timeframe: Month 9Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 \[satisfying\]) was reported for each of the MIRCERA parameters.
Outcome measures
| Measure |
MIRCERA
n=218 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Treatment
|
94.5 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Application
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94.5 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Preparation
|
95.1 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Storage
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94.5 percentage of participants
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Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
Disposal
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89.6 percentage of participants
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PRIMARY outcome
Timeframe: Baseline, Months 1-9Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe.
Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)' minus 'pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.
Outcome measures
| Measure |
MIRCERA
n=214 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Change From Baseline in Pain Sensation Using Visual Analogue Scale
Baseline (n =214)
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1.04 units on a scale
Standard Deviation 1.205
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Change From Baseline in Pain Sensation Using Visual Analogue Scale
Change at Month 1-9 (n = 178)
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0.33 units on a scale
Standard Deviation 1.258
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PRIMARY outcome
Timeframe: 9 monthsPopulation: Participant Satisfaction Set.
Outcome measures
| Measure |
MIRCERA
n=221 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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Percentage of Participants Who Reported Easement of Therapy With MIRCERA
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93.7 percentage of participants
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PRIMARY outcome
Timeframe: End of observation period (Month 9)Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MIRCERA
n=142 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Percentage of Participants Who Continued Treatment After End of Study
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84.5 percentage of participants
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PRIMARY outcome
Timeframe: 9 monthsPopulation: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MIRCERA
n=142 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Average Monthly Dose of MIRCERA
|
144.4 grams
Standard Deviation 105.50
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PRIMARY outcome
Timeframe: 9 monthsPopulation: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MIRCERA
n=142 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Number of MIRCERA Dose Adaptations
|
3.2 dose adaptations
Standard Deviation 2.03
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PRIMARY outcome
Timeframe: 9 monthsPopulation: Efficiency Set included all participants who had at least one MIRCERA application, without any major protocol violation and had prescription and application data available for 2 months before start of MIRCERA and first 2 months of study. Here N = participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MIRCERA
n=142 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Mean Monthly Administrations of MIRCERA
|
1.2 MIRCERA administrations per month
Standard Deviation 0.20
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PRIMARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9Population: Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe.
Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.
Outcome measures
| Measure |
MIRCERA
n=221 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
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|---|---|
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Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 1: -2 (n=221)
|
0.9 percentage of participants
|
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Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 1: -1 (n=221)
|
2.7 percentage of participants
|
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Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 1: 0 (n=221)
|
81.0 percentage of participants
|
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Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 1: 1 (n=221)
|
14.0 percentage of participants
|
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Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 1: 2 (n=221)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 1: No satisfaction rating (n=221)
|
1.4 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 2: -2 (n=218)
|
0.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 2: -1 (n=218)
|
1.4 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 2: 0 (n=218)
|
79.4 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 2: 1 (n=218)
|
14.7 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 2: 2 (n=218)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 2: No satisfaction rating (n=218)
|
3.6 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 3: -2 (n=213)
|
0.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 3: -1 (n=213)
|
0.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 3: 0 (n=213)
|
80.3 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 3: 1 (n=213)
|
14.1 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 3: 2 (n=213)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 3: No satisfaction rating (n=213)
|
3.8 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 4: -2 (n=210)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 4: -1 (n=210)
|
1.4 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 4: 0 (n=210)
|
78.6 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 4: 1
|
15.2 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 4: 2 (n=210)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 4: No satisfaction rating (n=210)
|
4.8 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 5: -2 (n=204)
|
1.0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 5: -1 (n=204)
|
1.0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 5: 0 (n=204)
|
79.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 5: 1 (n=204)
|
14.2 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 5: 2 (n=204)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 5: No satisfaction rating (n=204)
|
3.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 6: -2 (n=197)
|
1.0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 6: -1 (n=197)
|
1.5 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 6: 0 (n=197)
|
79.2 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 6: 1 (n=197)
|
14.2 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 6: 2 (n=197)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 6: No satisfaction rating (n=197)
|
4.1 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 7: -2 (n=192)
|
0.5 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 7: -1 (n=192)
|
0.5 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 7: 0 (n=192)
|
81.3 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 7: 1 (n=192)
|
13.5 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 7: 2 (n=192)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 7: No satisfaction rating (n=192)
|
4.2 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 8: -2 (n=187)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 8: -1 (n=187)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 8: 0 (n=187)
|
80.7 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 8: 1 (n=187)
|
14.4 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 8: 2 (n=187)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 8: No satisfaction rating (n=187)
|
4.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 9: -2 (n=183)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 9: -1 (n=183)
|
0.5 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 9: 0 (n=183)
|
80.9 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 9: 1 (n=183)
|
13.7 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 9: 2 (n=183)
|
0 percentage of participants
|
|
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
Month 9: No satisfaction rating (n=183)
|
4.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9Population: Secondary endpoint set included all participants who had at least one MIRCERA application, without any major protocol violation and had at least 6 months documentation and minimum 2 of the 3 visits non-missing Hb and dosing data from Month 7 to 9 visits. N=participants evaluable for this outcome and n=participants evaluable for specified timeframe.
Outcome measures
| Measure |
MIRCERA
n=171 Participants
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
|
|---|---|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 1 (n = 34)
|
0.02 g/dL
Standard Deviation 0.966
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 2 (n = 166)
|
-0.03 g/dL
Standard Deviation 1.230
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 3 (n = 163)
|
-0.26 g/dL
Standard Deviation 1.216
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 4 (n = 165)
|
-0.36 g/dL
Standard Deviation 1.191
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 5 (n = 161)
|
-0.31 g/dL
Standard Deviation 1.215
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 6 (n = 152)
|
-0.34 g/dL
Standard Deviation 1.128
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 7 (n = 171)
|
-0.38 g/dL
Standard Deviation 1.250
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 8 (n = 159)
|
-0.31 g/dL
Standard Deviation 1.294
|
|
Change From Baseline in Hemoglobin (Hb) Concentration
Month 9 (n = 86)
|
-0.29 g/dL
Standard Deviation 1.202
|
Adverse Events
MIRCERA
Serious events: 27 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MIRCERA
n=238 participants at risk
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
|
|---|---|
|
Investigations
Haemoglobin decreased
|
4.6%
11/238 • up to the end of study (9 months)
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Infections and infestations
Pneumonia
|
1.3%
3/238 • up to the end of study (9 months)
|
|
Infections and infestations
Febrile infection
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Infections and infestations
Cellulitis
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Infections and infestations
Erysipelas
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.84%
2/238 • up to the end of study (9 months)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Vascular disorders
Hypotension
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Vascular disorders
Extremity necrosis
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Vascular disorders
Diverticulum intestinal haemorrhagic
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Cardiac disorders
Bradycardia
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Cardiac disorders
Cardiac failure
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Cardiac disorders
Coronary artery disease
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Surgical and medical procedures
Arteriovenous shunt operation
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Infections and infestations
Diverticulitis
|
0.42%
1/238 • up to the end of study (9 months)
|
Other adverse events
| Measure |
MIRCERA
n=238 participants at risk
Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
|
|---|---|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Investigations
Haematocrit decreased
|
0.42%
1/238 • up to the end of study (9 months)
|
|
Investigations
Haemoglobin decreased
|
2.9%
7/238 • up to the end of study (9 months)
|
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