N/A
Completed N=240
Observational Study of MIRCERA in Users of Self-Application and Multidose Systems
Renal Anemia of Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02540213 ↗
Enrolled (actual)
240
Serious AEs
11.3%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment — 83.7 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment |
83.7 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1 |
93.7; 93.7; 95.9; 96.8; 92.3 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2 |
93.6; 92.7; 96.8; 96.8; 92.2 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3 |
93.9; 91.5; 94.4; 94.4; 89.7 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4 |
93.8; 91.4; 94.8; 94.8; 90.0 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5 |
93.6; 92.2; 96.1; 95.1; 91.2 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6 |
93.4; 92.4; 95.4; 95.4; 90.4 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7 |
94.8; 92.7; 94.3; 94.8; 89.1 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8 |
95.2; 94.1; 94.1; 94.7; 89.3 | — |
| PRIMARY Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9 |
94.5; 94.5; 95.1; 94.5; 89.6 | — |
| PRIMARY Change From Baseline in Pain Sensation Using Visual Analogue Scale |
1.04; 0.33 | — |
| PRIMARY Percentage of Participants Who Reported Easement of Therapy With MIRCERA |
93.7 | — |
| PRIMARY Percentage of Participants Who Continued Treatment After End of Study |
84.5 | — |
| PRIMARY Average Monthly Dose of MIRCERA |
144.4 | — |
| PRIMARY Number of MIRCERA Dose Adaptations |
3.2 | — |
| PRIMARY Mean Monthly Administrations of MIRCERA |
1.2 | — |
| PRIMARY Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment |
0.9; 2.7; 81.0; 14.0; 0; 1.4 | — |
| SECONDARY Change From Baseline in Hemoglobin (Hb) Concentration |
0.02; -0.03; -0.26; -0.36; -0.31; -0.34 | — |
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
Data sourced from ClinicalTrials.gov (NCT02540213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.