Renal Anemia of Chronic Kidney Disease
Conditions
Brief summary
This non-interventional, observational study investigates the efficiency, safety and acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA) using a self-application system. For each participant, the investigator documents 9 months of treatment with Mircera with respect to efficacy, safety and acceptance.
Interventions
DEVICEMIRCERA
Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Anemia caused by CKD only * Life expectancy of more than (\>) 9 months in the judgment of the attending physician * Ferritin \>200 micrograms per liter (mcg/L) in accordance with the relevant guidelines * The time point of changing to Mircera was only 3 months ago at the longest
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 | 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. |
| Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment | Baseline | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Month 1 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Month 2 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Month 3 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Month 4 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Month 5 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Month 6 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Month 7 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Month 8 | 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. |
| Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Month 9 | 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. |
| Change From Baseline in Pain Sensation Using Visual Analogue Scale | Baseline, Months 1-9 | 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. |
| Percentage of Participants Who Reported Easement of Therapy With MIRCERA | 9 months | — |
| Percentage of Participants Who Continued Treatment After End of Study | End of observation period (Month 9) | — |
| Average Monthly Dose of MIRCERA | 9 months | — |
| Number of MIRCERA Dose Adaptations | 9 months | — |
| Mean Monthly Administrations of MIRCERA | 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Hemoglobin (Hb) Concentration | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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). | 238 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reasons | 3 |
| Overall Study | Consent withdrawn | 7 |
| Overall Study | Death/adverse event | 18 |
| Overall Study | Enrolled but not treated | 2 |
| Overall Study | Kidney transplant | 3 |
| Overall Study | Lack of Efficacy | 6 |
Baseline characteristics
| Characteristic | MIRCERA |
|---|---|
| Age, Continuous | 66.8 years |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 238 |
| serious Total, serious adverse events | 27 / 238 |
Outcome results
Primary
Average Monthly Dose of MIRCERA
Time frame: 9 months
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRCERA | Average Monthly Dose of MIRCERA | 144.4 grams | Standard Deviation 105.5 |
Primary
Change From Baseline in Pain Sensation Using Visual Analogue Scale
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.
Time frame: Baseline, Months 1-9
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Change From Baseline in Pain Sensation Using Visual Analogue Scale | Baseline (n =214) | 1.04 units on a scale | Standard Deviation 1.205 |
| MIRCERA | Change From Baseline in Pain Sensation Using Visual Analogue Scale | Change at Month 1-9 (n = 178) | 0.33 units on a scale | Standard Deviation 1.258 |
Primary
Mean Monthly Administrations of MIRCERA
Time frame: 9 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRCERA | Mean Monthly Administrations of MIRCERA | 1.2 MIRCERA administrations per month | Standard Deviation 0.2 |
Primary
Number of MIRCERA Dose Adaptations
Time frame: 9 months
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRCERA | Number of MIRCERA Dose Adaptations | 3.2 dose adaptations | Standard Deviation 2.03 |
Primary
Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment | 83.7 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
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.
Time frame: Month 1
Population: Participant Satisfaction Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Treatment | 93.7 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Application | 93.7 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Preparation | 95.9 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Storage | 96.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 | Disposal | 92.3 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
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.
Time frame: Month 2
Population: Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Disposal | 92.2 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Treatment | 93.6 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Application | 92.7 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Preparation | 96.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 | Storage | 96.8 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
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.
Time frame: Month 3
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Treatment | 93.9 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Application | 91.5 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Preparation | 94.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Storage | 94.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 | Disposal | 89.7 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
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.
Time frame: Month 4
Population: Participant Satisfaction Set. Here N = participants who were available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Treatment | 93.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Application | 91.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Preparation | 94.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Storage | 94.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 | Disposal | 90.0 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
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.
Time frame: Month 5
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Application | 92.2 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Preparation | 96.1 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Treatment | 93.6 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Storage | 95.1 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 | Disposal | 91.2 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
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.
Time frame: Month 6
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Treatment | 93.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Application | 92.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Preparation | 95.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Storage | 95.4 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 | Disposal | 90.4 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
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.
Time frame: Month 7
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Treatment | 94.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Application | 92.7 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Preparation | 94.3 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Storage | 94.8 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 | Disposal | 89.1 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
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.
Time frame: Month 8
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Treatment | 95.2 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Application | 94.1 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Preparation | 94.1 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Storage | 94.7 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 | Disposal | 89.3 percentage of participants |
Primary
Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
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.
Time frame: Month 9
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Treatment | 94.5 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Application | 94.5 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Preparation | 95.1 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Storage | 94.5 percentage of participants |
| MIRCERA | Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 | Disposal | 89.6 percentage of participants |
Primary
Percentage of Participants Who Continued Treatment After End of Study
Time frame: End of observation period (Month 9)
Population: Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIRCERA | Percentage of Participants Who Continued Treatment After End of Study | 84.5 percentage of participants |
Primary
Percentage of Participants Who Reported Easement of Therapy With MIRCERA
Time frame: 9 months
Population: Participant Satisfaction Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIRCERA | Percentage of Participants Who Reported Easement of Therapy With MIRCERA | 93.7 percentage of participants |
Primary
Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
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.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Population: Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 1: 1 (n=221) | 14.0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 5: 0 (n=204) | 79.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 6: 0 (n=197) | 79.2 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 1: -2 (n=221) | 0.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 1: -1 (n=221) | 2.7 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 1: 0 (n=221) | 81.0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 1: 2 (n=221) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 1: No satisfaction rating (n=221) | 1.4 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 2: -2 (n=218) | 0.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 2: -1 (n=218) | 1.4 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 2: 0 (n=218) | 79.4 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 2: 1 (n=218) | 14.7 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 2: 2 (n=218) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 2: No satisfaction rating (n=218) | 3.6 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 3: -2 (n=213) | 0.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 3: -1 (n=213) | 0.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 3: 0 (n=213) | 80.3 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 3: 1 (n=213) | 14.1 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 3: 2 (n=213) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 3: No satisfaction rating (n=213) | 3.8 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 4: -2 (n=210) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 4: -1 (n=210) | 1.4 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 4: 0 (n=210) | 78.6 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 4: 1 | 15.2 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 4: 2 (n=210) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 4: No satisfaction rating (n=210) | 4.8 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 5: -2 (n=204) | 1.0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 5: -1 (n=204) | 1.0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 5: 1 (n=204) | 14.2 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 5: 2 (n=204) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 5: No satisfaction rating (n=204) | 3.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 6: -2 (n=197) | 1.0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 6: -1 (n=197) | 1.5 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 6: 1 (n=197) | 14.2 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 6: 2 (n=197) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 6: No satisfaction rating (n=197) | 4.1 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 7: -2 (n=192) | 0.5 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 7: -1 (n=192) | 0.5 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 7: 0 (n=192) | 81.3 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 7: 1 (n=192) | 13.5 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 7: 2 (n=192) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 7: No satisfaction rating (n=192) | 4.2 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 8: -2 (n=187) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 8: -1 (n=187) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 8: 0 (n=187) | 80.7 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 8: 1 (n=187) | 14.4 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 8: 2 (n=187) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 8: No satisfaction rating (n=187) | 4.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 9: -2 (n=183) | 0 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 9: -1 (n=183) | 0.5 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 9: 0 (n=183) | 80.9 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 9: 1 (n=183) | 13.7 percentage of participants |
| MIRCERA | Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment | Month 9: 2 (n=183) | 0 percentage of participants |
| MIRCERA | 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
Change From Baseline in Hemoglobin (Hb) Concentration
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 8 (n = 159) | -0.31 g/dL | Standard Deviation 1.294 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 1 (n = 34) | 0.02 g/dL | Standard Deviation 0.966 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 2 (n = 166) | -0.03 g/dL | Standard Deviation 1.23 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 3 (n = 163) | -0.26 g/dL | Standard Deviation 1.216 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 4 (n = 165) | -0.36 g/dL | Standard Deviation 1.191 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 5 (n = 161) | -0.31 g/dL | Standard Deviation 1.215 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 6 (n = 152) | -0.34 g/dL | Standard Deviation 1.128 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 7 (n = 171) | -0.38 g/dL | Standard Deviation 1.25 |
| MIRCERA | Change From Baseline in Hemoglobin (Hb) Concentration | Month 9 (n = 86) | -0.29 g/dL | Standard Deviation 1.202 |