Observational Study of MIRCERA in Users of Self-Application and Multidose Systems

Study Overview
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Brief Summary
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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.

Conditions
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Renal Anemia of Chronic Kidney Disease

Intervention / Treatment
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* Device: MIRCERA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MIRCERA Ready-To-Use-Syringe<br>Participants will use MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta 0.6 micrograms per kilogram [mcg/kg]) every 2 weeks (q2w) up to 9 months | Device: MIRCERA<br>* Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | Month 1 | 
| 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. | Month 2 | 
| 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. | Month 3 | 
| 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. | Month 4 | 
| 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. | Month 5 | 
| 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. | Month 6 | 
| 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. | Month 7 | 
| 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. | Month 8 | 
| 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. | Month 9 | 
| 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. | Baseline, Months 1-9 | 
| 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 | 
| 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. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin (Hb) Concentration |  | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |