Clinical trial NCT02540213: Observational Study of MIRCERA in Users of Self-Application and Multidose Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia of Chronic Kidney Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment
timeFrame: Baseline
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1
timeFrame: Month 1
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2
timeFrame: Month 2
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3
timeFrame: Month 3
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4
timeFrame: Month 4
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5
timeFrame: Month 5
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6
timeFrame: Month 6
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7
timeFrame: Month 7
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8
timeFrame: Month 8
measure: Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9
timeFrame: Month 9
measure: Change From Baseline in Pain Sensation Using Visual Analogue Scale
timeFrame: Baseline, Months 1-9
measure: Percentage of Participants Who Reported Easement of Therapy With MIRCERA
timeFrame: 9 months
measure: Percentage of Participants Who Continued Treatment After End of Study
timeFrame: End of observation period (Month 9)
measure: Average Monthly Dose of MIRCERA
timeFrame: 9 months
measure: Number of MIRCERA Dose Adaptations
timeFrame: 9 months
measure: Mean Monthly Administrations of MIRCERA
timeFrame: 9 months
measure: Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Secondary outcomes:
measure: Change From Baseline in Hemoglobin (Hb) Concentration
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Other outcomes:
Locations:
city: Daun
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: