Anemia
Conditions
Brief summary
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Chronic kidney disease in predialysis (stage 3 and 4) and dialysis * Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent
Exclusion criteria
* Participation in an interventional clinical trial within the retrospective observation period * Contraindications to Mircera administration as per label or judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Hemoglobin Cycling | 9 months | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (\>=) 1.5 gram per deciliter (g/dL) and a duration \>=8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Full Hemoglobin Cycles Per Participant | 9 months | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of \>=1.5 g/dL and a duration \>=8 weeks. |
| Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling | 9 months | Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of \>=1.5 g/dL and a duration \>=8 weeks. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mircera Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants' medical files. | 1,285 |
| Total | 1,285 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Dose data not recorded | 2 |
| Overall Study | Enrolled, but not treated | 3 |
Baseline characteristics
| Characteristic | Mircera |
|---|---|
| Age, Continuous | 70.13 years STANDARD_DEVIATION 13.75 |
| Sex: Female, Male Female | 570 Participants |
| Sex: Female, Male Male | 715 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With at Least One Hemoglobin Cycling
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (\>=) 1.5 gram per deciliter (g/dL) and a duration \>=8 weeks.
Time frame: 9 months
Population: Analysis population included all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera | Percentage of Participants With at Least One Hemoglobin Cycling | 31.84 percentage of participants |
Secondary
Number of Full Hemoglobin Cycles Per Participant
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of \>=1.5 g/dL and a duration \>=8 weeks.
Time frame: 9 months
Population: Analysis population included all treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mircera | Number of Full Hemoglobin Cycles Per Participant | 0.38 cycles | Standard Deviation 0.61 |
Secondary
Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of \>=1.5 g/dL and a duration \>=8 weeks.
Time frame: 9 months
Population: Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mircera | Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling | 29.83 percentage of participants |