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

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.

Study Overview

• Status: Completed
• Conditions: Renal Anemia of Chronic Kidney Disease
• Intervention / Treatment: Device: MIRCERA

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Germany
  • Daun, Germany, 54550

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MIRCERA Ready-To-Use-Syringe; 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; Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: ML21387