Anemia, Kidney Disease, Chronic
Conditions
Brief summary
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).
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 * Renal anemia treated with Mircera for at least 6 months before entering study
Exclusion criteria
* Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) | Up to 6 months | Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL | Up to 6 months | Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methoxy-Polyethylene-Glycol-Epoetin Beta Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study. | 780 |
| Total | 780 |
Baseline characteristics
| Characteristic | Methoxy-Polyethylene-Glycol-Epoetin Beta |
|---|---|
| Age, Continuous | 68.64 Years STANDARD_DEVIATION 14.1 |
| Sex/Gender, Customized Female | 442 Participants |
| Sex/Gender, Customized Male | 325 Participants |
| Sex/Gender, Customized Missing | 13 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 Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)
Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Time frame: Up to 6 months
Population: Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy-Polyethylene-Glycol-Epoetin Beta | Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL) | 17.18 Percentage of participants |
Secondary
Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL
Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.
Time frame: Up to 6 months
Population: Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methoxy-Polyethylene-Glycol-Epoetin Beta | Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL | 3.09 Percentage of participants |