Renal Anemia of Chronic Kidney Disease, Renal Impairment
Conditions
Brief summary
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.
Interventions
Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).
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
* Participants on peritoneal dialysis * Need for Erythropoiesis Stimulating Agent (ESA) therapy * Prescription of methoxy polyethylene glycol epoetin beta by the doctor
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | Month 7 to Month 9 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | Month 7 to Month 9 |
| Average Duration in Days Mircera Was Administered at a Stable Dose | Up to 9 months |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peritoneal Dialysis Participants Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months. | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Change to hemodialysis | 15 |
| Overall Study | Missing | 1 |
| Overall Study | No documentation of study drug dosing | 3 |
| Overall Study | Other | 32 |
| Overall Study | Other Erythropoietin stimulating agent | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Peritoneal Dialysis Participants |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 15.1 |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 220 |
| serious Total, serious adverse events | 0 / 220 |
Outcome results
Primary
Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
Time frame: Month 7 to Month 9
Population: Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peritoneal Dialysis Participants | Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | 14.8 percentage of participants |
Secondary
Average Duration in Days Mircera Was Administered at a Stable Dose
Time frame: Up to 9 months
Population: MES population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peritoneal Dialysis Participants | Average Duration in Days Mircera Was Administered at a Stable Dose | 182.1 days | Standard Deviation 122.7 |
Secondary
Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
Time frame: Month 7 to Month 9
Population: MES population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peritoneal Dialysis Participants | Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) | 38.9 percentage of participants |