Anemia, Kidney Disease, Chronic
Conditions
Brief summary
This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.
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 patients, \>/= 18 years of age * Stage IV chronic kidney disease, on haemodialysis * Chronic renal anemia, on maintenance ESA treatment * Hemoglobin concentration between 10.0 an 12 g/dL * Continuous maintenance epoetin therapy with the same dosing interval during the previous month
Exclusion criteria
* Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension) * Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) * Anemia due to hemolysis, pure red cell aplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 12 months | AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs. |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin Levels | Baseline; Weeks 8, 16, 24, 48 |
Countries
North Macedonia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mircera Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling. | 184 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case record form not evaluated | 1 |
| Overall Study | Lost to Follow-up | 37 |
Baseline characteristics
| Characteristic | Mircera |
|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 184 |
| serious Total, serious adverse events | 22 / 184 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.
Time frame: Up to 12 months
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mircera | Number of Participants With Adverse Events (AEs) | Any AE | 49 participants |
| Mircera | Number of Participants With Adverse Events (AEs) | SAE | 22 participants |
Secondary
Hemoglobin Levels
Time frame: Baseline; Weeks 8, 16, 24, 48
Population: Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mircera | Hemoglobin Levels | Baseline (n=184) | 110.3 gram per liter | Standard Deviation 8.671274 |
| Mircera | Hemoglobin Levels | Week 8 (n=179) | 110.8 gram per liter | Standard Deviation 13.31517 |
| Mircera | Hemoglobin Levels | Week 16 (n=155) | 111.3 gram per liter | Standard Deviation 14.9725 |
| Mircera | Hemoglobin Levels | Week 24 (n=161) | 111.2 gram per liter | Standard Deviation 14.93382 |
| Mircera | Hemoglobin Levels | Week 48 (n=130) | 111.2 gram per liter | Standard Deviation 13.5594 |