An observational study in Renal Anemia of Chronic Kidney Disease, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-22.
Sponsored by Hoffmann-La Roche · Observational
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 240 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with chronic kidney disease who received ESA therapy or multidose system before they changed to MIRCERA
Exclusion Criteria:
N/A
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Months 1-9
Percentage of Participants Who Reported Easement of Therapy With MIRCERA
Time frame: 9 months
Percentage of Participants Who Continued Treatment After End of Study
Time frame: End of observation period (Month 9)
Average Monthly Dose of MIRCERA
Time frame: 9 months
Number of MIRCERA Dose Adaptations
Time frame: 9 months
Mean Monthly Administrations of MIRCERA
Time frame: 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.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
Change From Baseline in Hemoglobin (Hb) Concentration
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9
| Milestone | MIRCERA |
|---|---|
| Started | 240 |
| Completed | 201 |
| Not completed | 39 |
| Withdrew: Death/adverse event | 18 |
| Withdrew: Administrative reasons | 3 |
| Withdrew: Kidney transplant | 3 |
| Withdrew: Lack of efficacy | 6 |
| Withdrew: Consent withdrawn | 7 |
| Withdrew: Enrolled but not treated | 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 \[satisfying\]) 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.
| percentage of participants | MIRCERA |
|---|---|
| Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment | 83.7 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 93.7 |
| Application | 93.7 |
| Preparation | 95.9 |
| Storage | 96.8 |
| Disposal | 92.3 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 93.6 |
| Application | 92.7 |
| Preparation | 96.8 |
| Storage | 96.8 |
| Disposal | 92.2 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 93.9 |
| Application | 91.5 |
| Preparation | 94.4 |
| Storage | 94.4 |
| Disposal | 89.7 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 93.8 |
| Application | 91.4 |
| Preparation | 94.8 |
| Storage | 94.8 |
| Disposal | 90.0 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 93.6 |
| Application | 92.2 |
| Preparation | 96.1 |
| Storage | 95.1 |
| Disposal | 91.2 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 93.4 |
| Application | 92.4 |
| Preparation | 95.4 |
| Storage | 95.4 |
| Disposal | 90.4 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 94.8 |
| Application | 92.7 |
| Preparation | 94.3 |
| Storage | 94.8 |
| Disposal | 89.1 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 95.2 |
| Application | 94.1 |
| Preparation | 94.1 |
| Storage | 94.7 |
| Disposal | 89.3 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Treatment | 94.5 |
| Application | 94.5 |
| Preparation | 95.1 |
| Storage | 94.5 |
| Disposal | 89.6 |
| g/dL | MIRCERA |
|---|---|
| Month 1 (n = 34) | 0.02 ± 0.966 |
| Month 2 (n = 166) | -0.03 ± 1.230 |
| Month 3 (n = 163) | -0.26 ± 1.216 |
| Month 4 (n = 165) | -0.36 ± 1.191 |
| Month 5 (n = 161) | -0.31 ± 1.215 |
| Month 6 (n = 152) | -0.34 ± 1.128 |
| Month 7 (n = 171) | -0.38 ± 1.250 |
| Month 8 (n = 159) | -0.31 ± 1.294 |
| Month 9 (n = 86) | -0.29 ± 1.202 |
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.
| units on a scale | MIRCERA |
|---|---|
| Baseline (n =214) | 1.04 ± 1.205 |
| Change at Month 1-9 (n = 178) | 0.33 ± 1.258 |
| percentage of participants | MIRCERA |
|---|---|
| Percentage of Participants Who Reported Easement of Therapy With MIRCERA | 93.7 |
| percentage of participants | MIRCERA |
|---|---|
| Percentage of Participants Who Continued Treatment After End of Study | 84.5 |
| grams | MIRCERA |
|---|---|
| Average Monthly Dose of MIRCERA | 144.4 ± 105.50 |
| dose adaptations | MIRCERA |
|---|---|
| Number of MIRCERA Dose Adaptations | 3.2 ± 2.03 |
| MIRCERA administrations per month | MIRCERA |
|---|---|
| Mean Monthly Administrations of MIRCERA | 1.2 ± 0.20 |
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.
| percentage of participants | MIRCERA |
|---|---|
| Month 1: -2 (n=221) | 0.9 |
| Month 1: -1 (n=221) | 2.7 |
| Month 1: 0 (n=221) | 81.0 |
| Month 1: 1 (n=221) | 14.0 |
| Month 1: 2 (n=221) | 0 |
| Month 1: No satisfaction rating (n=221) | 1.4 |
| Month 2: -2 (n=218) | 0.9 |
| Month 2: -1 (n=218) | 1.4 |
| Month 2: 0 (n=218) | 79.4 |
| Month 2: 1 (n=218) | 14.7 |
| Month 2: 2 (n=218) | 0 |
| Month 2: No satisfaction rating (n=218) | 3.6 |
| Month 3: -2 (n=213) | 0.9 |
| Month 3: -1 (n=213) | 0.9 |
| Month 3: 0 (n=213) | 80.3 |
| Month 3: 1 (n=213) | 14.1 |
| Month 3: 2 (n=213) | 0 |
| Month 3: No satisfaction rating (n=213) | 3.8 |
| Month 4: -2 (n=210) | 0 |
| Month 4: -1 (n=210) | 1.4 |
| Month 4: 0 (n=210) | 78.6 |
| Month 4: 1 | 15.2 |
| Month 4: 2 (n=210) | 0 |
| Month 4: No satisfaction rating (n=210) | 4.8 |
| Month 5: -2 (n=204) | 1.0 |
| Month 5: -1 (n=204) | 1.0 |
| Month 5: 0 (n=204) | 79.9 |
| Month 5: 1 (n=204) | 14.2 |
| Month 5: 2 (n=204) | 0 |
| Month 5: No satisfaction rating (n=204) | 3.9 |
| Month 6: -2 (n=197) | 1.0 |
| Month 6: -1 (n=197) | 1.5 |
| Month 6: 0 (n=197) | 79.2 |
| Month 6: 1 (n=197) | 14.2 |
| Month 6: 2 (n=197) | 0 |
| Month 6: No satisfaction rating (n=197) | 4.1 |
| Month 7: -2 (n=192) | 0.5 |
| Month 7: -1 (n=192) | 0.5 |
| Month 7: 0 (n=192) | 81.3 |
| Month 7: 1 (n=192) | 13.5 |
| Month 7: 2 (n=192) | 0 |
| Month 7: No satisfaction rating (n=192) | 4.2 |
| Month 8: -2 (n=187) | 0 |
| Month 8: -1 (n=187) | 0 |
| Month 8: 0 (n=187) | 80.7 |
| Month 8: 1 (n=187) | 14.4 |
| Month 8: 2 (n=187) | 0 |
| Month 8: No satisfaction rating (n=187) | 4.9 |
| Month 9: -2 (n=183) | 0 |
| Month 9: -1 (n=183) | 0.5 |
| Month 9: 0 (n=183) | 80.9 |
| Month 9: 1 (n=183) | 13.7 |
| Month 9: 2 (n=183) | 0 |
| Month 9: No satisfaction rating (n=183) | 4.9 |
Collected over up to the end of study (9 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MIRCERA | — | 27/238 (11.3%) | 9/238 (3.8%) |
| Event | MIRCERA |
|---|---|
| Haemoglobin decreasedInvestigations | 11/238 |
| PneumoniaInfections and infestations | 3/238 |
| Shunt occlusionInjury, poisoning and procedural complications | 2/238 |
| Gastrointestinal ulcer haemorrhageGastrointestinal disorders | 1/238 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/238 |
| Colitis ischaemicGastrointestinal disorders | 1/238 |
| Febrile infectionInfections and infestations | 1/238 |
| CellulitisInfections and infestations | 1/238 |
| ErysipelasInfections and infestations | 1/238 |
| Shunt malfunctionInjury, poisoning and procedural complications | 1/238 |
| Event | MIRCERA |
|---|---|
| Haemoglobin decreasedInvestigations | 7/238 |
| Nephrogenic anaemiaBlood and lymphatic system disorders | 1/238 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/238 |
| Subcutaneous haematomaInjury, poisoning and procedural complications | 1/238 |
| Haematocrit decreasedInvestigations | 1/238 |
Safety set included all participants who had at least one MIRCERA application.
| Age, Continuous(years) | MIRCERA |
|---|---|
| Mean | 66.8 (24 to 93) |
| Sex: Female, Male(Participants) | MIRCERA |
|---|---|
| Female | 109 |
| Male | 129 |
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