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

Completed

• Conditions: Renal Anemia of Chronic Kidney Disease
• Interventions: Device: MIRCERA

• Registration Number: NCT02540213
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-03
• Status Verified: 2015-11
• Results First Submitted: 2015-11-18
• Results First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Results First Posted: 2015-12-22
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

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Exclusion Criteria

N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIRCERA Ready-To-Use-Syringe	MIRCERA	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

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin (Hb) Concentration	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9