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

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ClinicalTrials.gov Identifier: NCT02540213
Recruitment Status : Completed
First Posted : September 3, 2015
Results First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment
Renal Anemia of Chronic Kidney Disease Device: MIRCERA

Study Design
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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Change From Baseline in Hemoglobin (Hb) Concentration [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540213


Locations
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Germany
Daun, Germany, 54550
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02540213    
Other Study ID Numbers: ML21387
First Posted: September 3, 2015    Key Record Dates
Results First Posted: December 22, 2015
Last Update Posted: December 22, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency