Anemia
Conditions
Brief summary
This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants, \>/= 18 years of age * Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4) * Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment) * Life expectancy \> 10 months
Exclusion criteria
* Malignant disease * Significant or acute bleeding * Poorly controlled hypertension * Blood transfusion during the previous 2 months * Hypersensitivity to Mircera or any of its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 | Months 8 to 10 | g/dL = grams per deciliter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | Months 8 to 10 | g/dL = grams per deciliter |
| Percentage of Participants With MIRCERA Dose Adjustments | Up to 10 months | Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated. |
| Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs | Up to 10 months | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With CKD This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice. | 437 |
| Total | 437 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 41 |
| Overall Study | Lost to Follow-up | 35 |
| Overall Study | Withdrawal of participant's consent | 7 |
Baseline characteristics
| Characteristic | Participants With CKD |
|---|---|
| Age, Continuous | 76 years |
| Sex: Female, Male Female | 230 Participants |
| Sex: Female, Male Male | 207 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 437 |
| serious Total, serious adverse events | 56 / 437 |
Outcome results
Primary
Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
g/dL = grams per deciliter
Time frame: Months 8 to 10
Population: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With CKD | Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 | 51.2 percentage of participants |
Secondary
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.
Time frame: Up to 10 months
Population: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With CKD | Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs | Serious AEs | 56 Participants |
| Participants With CKD | Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs | Non-Serious AEs | 37 Participants |
Secondary
Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10
g/dL = grams per deciliter
Time frame: Months 8 to 10
Population: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With CKD | Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | 10.0 - 13.0 g/dL | 68.8 percentage of participants |
| Participants With CKD | Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | 11.0 - 12.0 g/dL | 35.4 percentage of participants |
| Participants With CKD | Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10 | 11.0 - 13.0 g/dL | 53 percentage of participants |
Secondary
Percentage of Participants With MIRCERA Dose Adjustments
Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.
Time frame: Up to 10 months
Population: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. Number analyzed indicates number of participants evaluated at specific time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 1 Month, Dose Decreased | 13 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 2 Months, Dose Decreased | 12.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 3 Months, Dose Decreased | 10.6 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 4 Months, Dose Decreased | 11 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 5 Months, Dose Decreased | 11.6 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 6 Months, Dose Decreased | 10.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 7 Months, Dose Decreased | 10.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 8 Months, Dose Decreased | 9.6 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 9 Months, Dose Decreased | 8.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 10 Months, Dose Decreased | 8.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 1 Month, Same Dose | 58 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 2 Months, Same Dose | 54 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 3 Months, Same Dose | 54.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 4 Months, Same Dose | 50.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 5 Months, Same Dose | 53.8 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 6 Months, Same Dose | 51 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 7 Months, Same Dose | 54.6 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 8 Months, Same Dose | 55.8 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 9 Months, Same Dose | 60 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 10 Months, Same Dose | 59.6 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 1 Month, Dose Increased | 18.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 2 Months, Dose Increased | 14.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 3 Months, Dose Increased | 12.8 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 4 Months, Dose Increased | 12.8 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 5 Months, Dose Increased | 10.6 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 6 Months, Dose Increased | 14.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 7 Months, Dose Increased | 10.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 8 Months, Dose Increased | 9.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 9 Months, Dose Increased | 9.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 10 Months, Dose Increased | 11.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 1 Month, Data Not Reported | 10.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 2 Months, Data Not Reported | 19.2 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 3 Months, Data Not Reported | 22.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 4 Months, Data Not Reported | 25.8 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 5 Months, Data Not Reported | 24 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 6 Months, Data Not Reported | 24.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 7 Months, Data Not Reported | 24.8 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 8 Months, Data Not Reported | 25.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 9 Months, Data Not Reported | 22.4 percentage of participants |
| Participants With CKD | Percentage of Participants With MIRCERA Dose Adjustments | 10 Months, Data Not Reported | 21 percentage of participants |