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

NCT02540213 | Completed Results

• 1 other identifier: ML21387
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (1)

• Change From Baseline in Hemoglobin (Hb) Concentration

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

Study Arms (1)

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

Interventions

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.

MIRCERA Ready-To-Use-Syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Daun, 54550, Germany

Location

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 22, 2015
• Results First Posted: December 22, 2015

Record last verified: 2015-11

Locations

DE (1)