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Completed

NCT Number: NCT02540213

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.

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Key information

Conditions

Renal Anemia of Chronic Kidney Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Daun, 54550, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIRCERA

Device

Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.

Primary outcomes

  1. Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment

    Time frame: 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.

  2. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1

    Time frame: 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.

  3. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2

    Time frame: 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.

  4. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3

    Time frame: 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.

  5. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4

    Time frame: 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.

  6. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5

    Time frame: 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.

  7. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6

    Time frame: 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.

  8. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7

    Time frame: 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.

  9. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8

    Time frame: 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.

  10. Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9

    Time frame: 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.

  11. Change From Baseline in Pain Sensation Using Visual Analogue Scale

    Time frame: 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.

  12. Percentage of Participants Who Reported Easement of Therapy With MIRCERA

    Time frame: 9 months

  13. Percentage of Participants Who Continued Treatment After End of Study

    Time frame: End of observation period (Month 9)

  14. Average Monthly Dose of MIRCERA

    Time frame: 9 months

  15. Number of MIRCERA Dose Adaptations

    Time frame: 9 months

  16. Mean Monthly Administrations of MIRCERA

    Time frame: 9 months

  17. Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment

    Time frame: 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 outcomes

  1. Change From Baseline in Hemoglobin (Hb) Concentration

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2015
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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